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Clinical Trial Results:
First-in-human, Open-label, Dose-escalation Trial With Expansion cohorts to Evaluate Safety of GEN1029 in Patients with Malignant Solid Tumors

Summary
EudraCT number	2017-001394-16
Trial protocol	GB ES FR
Global end of trial date	12 Oct 2021

Results information
Results version number	v1(current)
This version publication date	26 Oct 2022
First version publication date	26 Oct 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

GCT1029-01

ISRCTN number

US NCT number

NCT03576131

WHO universal trial number (UTN)

Sponsor organisation name

Genmab B.V

Sponsor organisation address

3584 CM, Uterect, Netherlands,

Public contact

Clinical Trial Information, Genmab , +45 7020 2728, clinicaltrials@genmab.com

Scientific contact

Clinical Trial Information, Genmab , +45 7020 2728, clinicaltrials@genmab.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

23 Mar 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

12 Oct 2021

Was the trial ended prematurely?

Yes

Main objective of the trial

The main objective of the dose escalation part of the study was to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and to establish the safety profile of GEN1029 in participants with malignant solid tumors. The main objective of the dose expansion part of the study was to evaluate the objective response rate by indication.

Protection of trial subjects

The trial was conducted in accordance with the protocol and amendments, the International Council for Harmonisation E6 guideline for Good Clinical Practice, applicable local regulations, and ethical principles that have their origins in the Declaration of Helsinki. In addition, the trial was conducted in accordance with FDA 21 Code of Federal Regulations parts 312, 50, and 56, and the directive 2001/20/EC of the European Parliament.

Background therapy

Evidence for comparator

Actual start date of recruitment

30 Apr 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 13

Country: Number of subjects enrolled

United Kingdom: 15

Country: Number of subjects enrolled

United States: 20

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

The sponsor decided to halt the development of GEN1029 due to a narrow therapeutic window after the dose-escalation part, hence the expansion part of the trial was not performed. Therefore, results are reported here only for the dose-escalation part.

Period 1 title

Overall period

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Biweekly Regimen (GEN1029 0.1 mg/ kg)

Arm description

Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.

Arm type

Experimental

Investigational medicinal product name

GEN1029

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

GEN1029 0.1 mg/kg was administered intravenously Q2W until the end of treatment.

Biweekly Regimen (GEN1029 0.2 mg/kg)

Arm description

Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment

Arm type

Experimental

Investigational medicinal product name

GEN1029

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

GEN1029 0.2 mg/kg was administered intravenously Q2W until the end of treatment.

Biweekly Regimen (GEN1029 0.3 mg/kg)

Arm description

Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.

Arm type

Experimental

Investigational medicinal product name

GEN1029

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

GEN1029 0.3 mg/kg was administered intravenously Q2W until the end of treatment.

Biweekly Regimen (GEN1029 1.0 mg/kg)

Arm description

Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.

Arm type

Experimental

Investigational medicinal product name

GEN1029

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

GEN1029 1.0 mg/kg was administered intravenously Q2W until the end of treatment.

Biweekly Regimen (GEN1029 2.0 mg/kg)

Arm description

Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.

Arm type

Experimental

Investigational medicinal product name

GEN1029

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

GEN1029 2.0 mg/kg was administered intravenously Q2W until the end of treatment.

Biweekly Regimen (GEN1029 3.0 mg/kg)

Arm description

Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.

Arm type

Experimental

Investigational medicinal product name

GEN1029

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

GEN1029 3.0 mg/kg was administered intravenously Q2W until the end of treatment.

Priming Regimen (GEN1029 0.1 mg/kg)

Arm description

Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.

Arm type

Experimental

Investigational medicinal product name

GEN1029

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

GEN1029 0.1 mg/kg was administered intravenously on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, full dose of 0.3 mg/kg was administered until the end of treatment.

Intensified Regimen (GEN1029 1.0 mg/kg)

Arm description

Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.

Arm type

Experimental

Investigational medicinal product name

GEN1029

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

GEN1029 1.0 mg/kg was administered intravenously Q1W for the first 8 weeks then Q2W until the end of treatment.

Number of subjects in period 1	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)	Priming Regimen (GEN1029 0.1 mg/kg)	Intensified Regimen (GEN1029 1.0 mg/kg)
Started	10	7	4	11	7	7	1	1
Completed	1	2	0	0	0	0	0	0
Not completed	9	5	4	11	7	7	1	1
Adverse event, serious fatal	1	2	-	3	1	-	-	-
Consent withdrawn by subject	1	1	-	1	2	3	1	-
Subject non-compliance	-	-	-	-	-	1	-	-
Death	2	1	1	2	3	1	-	1
Investigator decision	-	-	-	1	-	1	-	-
Unspecified	-	-	1	1	1	1	-	-
New anti-cancer treatment	5	1	2	3	-	-	-	-

Baseline characteristics

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Reporting group title

Biweekly Regimen (GEN1029 0.1 mg/ kg)

Reporting group description

Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 0.2 mg/kg)

Reporting group description

Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment

Reporting group title

Biweekly Regimen (GEN1029 0.3 mg/kg)

Reporting group description

Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 1.0 mg/kg)

Reporting group description

Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 2.0 mg/kg)

Reporting group description

Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 3.0 mg/kg)

Reporting group description

Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Priming Regimen (GEN1029 0.1 mg/kg)

Reporting group description

Reporting group title

Intensified Regimen (GEN1029 1.0 mg/kg)

Reporting group description

Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.

Reporting group values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)	Priming Regimen (GEN1029 0.1 mg/kg)	Intensified Regimen (GEN1029 1.0 mg/kg)	Total
Number of subjects	10	7	4	11	7	7	1	1	48
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0	0
Adults (18-64 years)	7	3	2	7	3	4	1	0	27
From 65-84 years	3	4	2	4	4	3	0	1	21
85 years and over	0	0	0	0	0	0	0	0	0
Gender categorical
Units: Subjects
Female	6	1	2	8	5	4	1	0	27
Male	4	6	2	3	2	3	0	1	21

End points

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Reporting group title

Biweekly Regimen (GEN1029 0.1 mg/ kg)

Reporting group description

Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 0.2 mg/kg)

Reporting group description

Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment

Reporting group title

Biweekly Regimen (GEN1029 0.3 mg/kg)

Reporting group description

Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 1.0 mg/kg)

Reporting group description

Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 2.0 mg/kg)

Reporting group description

Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 3.0 mg/kg)

Reporting group description

Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Priming Regimen (GEN1029 0.1 mg/kg)

Reporting group description

Reporting group title

Intensified Regimen (GEN1029 1.0 mg/kg)

Reporting group description

Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.

Primary: Number of Participants with Dose Limiting Toxicities (DLTs)

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End point title

Number of Participants with Dose Limiting Toxicities (DLTs) ^[1] ^[2]

End point description

DLT criteria are defined haematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, >=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =<G1 within 24 hours, >=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7 days), or Hy’s law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any >=G3 possibly related non-haematological AE, which occurred during first 2 cycles (as specified in protocol). Dose-Determining Set (DDS) consists of all participants who received at least one dose of GEN1029 (between 80% and 125% of the planned dose), analyzed according to the actual trial treatment received, and completed DLT observation period, or experienced a DLT during Cycle

End point type

Primary

End point timeframe

From Day 1 to 28 days after the first dose of study drug

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	10	6	3	10	7	5
Units: Participants	0	1	0	3	3	2

No statistical analyses for this end point

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

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End point title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) ^[3] ^[4]

End point description

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is 'medically important']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period. The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.

End point type

Primary

End point timeframe

Day 1 through Day 565 (corresponding to maximum observed duration)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	10	7	4	11	7	7
Units: Participants
Any TEAE	8	7	4	11	7	7
Any TESAE	3	3	2	9	6	4

No statistical analyses for this end point

Primary: Number of Participants With >= Grade 3 Laboratory Results

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End point title

Number of Participants With >= Grade 3 Laboratory Results ^[5] ^[6]

End point description

Number of participants with laboratory measurements of >= Grade 3 by NCI-CTCAE v4.03 are reported.

End point type

Primary

End point timeframe

Day 1 through Day 565 (corresponding to maximum observed duration)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	10	7	4	11	7	7
Units: Participants
Prolonged activated partial thromboplastin time	0	1	0	0	0	0
Alanine aminotransferase increased	1	1	2	3	1	2
Alkaline phosphatase increased	0	0	1	0	1	0
Amylase increased	0	1	1	0	0	0
Asparate aminotransferase increased	1	2	0	0	0	2
Bilirubin increased	0	0	0	1	0	0
Calcium decreased	0	1	0	0	0	0
Creatinine increased	1	0	0	0	0	0
Gamma-glutamyl transferase increased	2	2	1	2	3	1
Glucose increased	2	1	1	3	0	0
Hemoglobin decreased	0	1	0	0	0	0
Lipase increased	1	0	3	1	0	0
Lymphocytes decreased	2	3	1	2	2	0
Magnesium increased	0	9	0	0	0	1
Prothrombin INR - increased	0	1	0	0	2	0
Sodium decreased	1	1	1	1	0	1
Urate increased	0	1	0	0	0	0

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05

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End point title

Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05 ^[7]

End point description

The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported. Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. Here, 'n' denotes the number of participants evaluated for the specified time point. The arbitrary number ‘99999.0’ denotes the data for geometric coefficient of variation, which was not reached because insufficient number of participants were evaluated for the specified time point.

End point type

Secondary

End point timeframe

Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	11	7	6
Units: µg/mL
geometric mean (geometric coefficient of variation)
Cmax Hx-DR5-01 Cycle 1 Day 1 (n=9,6,4,11,7,6)	0.86 ± 36.8	1.90 ± 38.0	2.81 ± 28.9	9.79 ± 20.9	21.31 ± 24.6	29.75 ± 24.9
Cmax Hx-DR5-01 Cycle 2 Day 1 (n=9,4,4,8,5,2)	0.79 ± 42.9	2.11 ± 18.3	1.12 ± 59.9	8.36 ± 22.7	13.13 ± 156.3	29.56 ± 7.7
Cmax Hx-DR5-01 Cycle 3 Day 1 (n=7,4,3,6,3,1)	0.89 ± 16.6	1.82 ± 53.9	0.89 ± 146.4	7.20 ± 11.2	20.35 ± 24.7	28.80 ± 99999.0
Cmax Hx-DR5-05 Cycle 1 Day 1 (n=9,6,4,11,7,6)	0.87 ± 45.2	1.81 ± 35.7	2.82 ± 31.8	9.72 ± 17.0	20.90 ± 21.9	29.44 ± 27.9
Cmax Hx-DR5-05 Cycle 2 Day 1 (n=9,4,4,8,4,2)	0.79 ± 25.9	2.00 ± 18.3	1.11 ± 76.2	7.75 ± 25.8	20.37 ± 14.3	30.52 ± 5.8
Cmax Hx-DR5-05 Cycle 3 Day 1 (n=7,4,2,6,3,1)	0.87 ± 26.6	1.28 ± 93.8	1.62 ± 108.2	6.77 ± 20.6	5.27 ± 577.8	28.50 ± 99999.0

No statistical analyses for this end point

Secondary: Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05

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End point title

Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05 ^[8]

End point description

The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported. PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. Here, 'n' denotes the number of participants evaluated for the specified time point. The arbitrary number ‘99999.0’ denotes the data for geometric coefficient of variation, which was not reached because insufficient number of participants were evaluated for the specified time point.

End point type

Secondary

End point timeframe

Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	11	7	6
Units: µg*h/mL
geometric mean (geometric coefficient of variation)
AUC(0-inf) Hx-DR5-01 Cycle1 Day1 (n=8,6,4,11,7,6)	39.44 ± 50.2	91.20 ± 66.0	85.80 ± 56.7	523.66 ± 47.5	1298.0 ± 22.7	1497.7 ± 58.7
AUC(0-inf) Hx-DR5-01 Cycle2 Day1 (n=8,4,4,7,4,2)	46.37 ± 61.5	105.32 ± 55.8	35.24 ± 30.5	530.48 ± 24.8	1071.5 ± 30.7	2488.5 ± 10.7
AUC(0-inf) Hx-DR5-01 Cycle3 Day1 (6,4,2,6,3,1)	37.43 ± 74.0	53.24 ± 133.3	41.41 ± 84.9	422.32 ± 26.8	1097.8 ± 36.6	2653.5 ± 9999.0
AUC(0-inf) Hx-DR5-05 Cycle1 Day1 (n=8,6,4,11,6,6)	32.97 ± 55.4	71.21 ± 66.9	83.37 ± 51.7	508.76 ± 33.0	1052.1 ± 24.7	1270.0 ± 60.1
AUC(0-inf) Hx-DR5-05 Cycle2 Day1 (7,4,3,6,3,2)	39.31 ± 65.9	93.11 ± 66.6	44.76 ± 184.4	414.90 ± 24.1	609.90 ± 55.2	2273.6 ± 9.0
AUC(0-inf) Hx-DR5-05 Cycle3 Day1 (n=5,3,2,6,2,1)	25.87 ± 57.3	51.36 ± 161.6	67.23 ± 200.5	231.49 ± 53.2	412.87 ± 64.1	2398.5 ± 9999.0

No statistical analyses for this end point

Secondary: Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05

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End point title

Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05 ^[9]

End point description

The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported. PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. Here, 'n' denotes the number of participants evaluated for the specified time point. The arbitrary number ‘99999.0’ denotes the data for geometric coefficient of variation, which was not reached because insufficient number of participants were evaluated for the specified time point.

End point type

Secondary

End point timeframe

Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	11	7	6
Units: µg*h/mL
geometric mean (geometric coefficient of variation)
AUC(0-Clast) Hx-DR5-01 Cycle1Day1 (n=9,6,4,11,7,6)	24.36 ± 73.2	72.25 ± 70.6	60.78 ± 35.8	460.37 ± 43.5	1173.7 ± 15.6	1058.9 ± 88.6
AUC(0-Clast) Hx-DR5-01 Cycle2Day1 (n=9,4,4,8,5,2)	17.34 ± 141.3	70.33 ± 66.4	21.85 ± 36.0	308.74 ± 66.8	582.57 ± 84.8	2291.4 ± 18.1
AUC(0-Clast) Hx-DR5-01 Cycle3Day1 (n=7,4,3,6,3,1)	22.34 ± 85.9	35.31 ± 151.4	6.85 ± 995.0	385.54 ± 23.7	986.38 ± 30.1	2444.7 ± 99999.0
AUC(0-Clast) Hx-DR5-05 Cycle1Day1 (n=9,6,4,11,7,6)	25.41 ± 120.7	53.76 ± 77.0	53.80 ± 50.8	432.18 ± 24.5	956.02 ± 18.8	964.48 ± 91.1
AUC(0-Clast) Hx-DR5-05 Cycle2Day1 (n=9,4,4,8,4,2)	24.85 ± 119.4	60.75 ± 76.0	29.17 ± 165.1	258.67 ± 60.5	395.50 ± 62.3	2176.0 ± 11.7
AUC(0-Clast) Hx-DR5-05 Cycle3Day1 (n=7,4,2,6,3,1)	20.12 ± 168.7	16.95 ± 539.4	43.56 ± 405.4	158.98 ± 76.4	52.16 ± 22162.5	2248.1 ± 99999.0

No statistical analyses for this end point

Secondary: Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05

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End point title

Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05 ^[10]

End point description

The CL of Hx-DR5-01 and Hx-DR5-05 are reported. PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. Here, 'n' denotes the number of participants evaluated for the specified time point. The arbitrary number ‘99999.0’ denotes the data for geometric coefficient of variation, which was not reached because insufficient number of participants were evaluated for the specified time point.

End point type

Secondary

End point timeframe

Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	11	7	6
Units: mL/h
geometric mean (geometric coefficient of variation)
CL Hx-DR5-01 Cycle 1 Day 1 (n=8,6,4,11,7,6)	95.98 ± 53.8	91.27 ± 51.4	123.75 ± 69.9	65.36 ± 56.5	59.07 ± 31.4	69.50 ± 51.0
CL Hx-DR5-01 Cycle 2 Day 1 (n=8,4,4,7,4,2)	77.36 ± 70.2	79.97 ± 51.8	155.76 ± 72.6	58.07 ± 31.8	73.43 ± 28.0	36.92 ± 2.0
CL Hx-DR5-01 Cycle 3 Day 1 (n=6,4,2,6,3,1)	99.53 ± 57.1	131.46 ± 76.0	111.33 ± 12.9	62.90 ± 42.5	62.64 ± 26.1	37.87 ± 99999.0
CL Hx-DR5-05 Cycle 1 Day 1 (n=8,6,4,11,6,6)	111.10 ± 62.5	116.89 ± 51.3	127.35 ± 69.3	67.28 ± 37.4	69.39 ± 29.2	81.96 ± 53.9
CL Hx-DR5-05 Cycle 2 Day 1 (n=7,4,3,6,3,2)	90.18 ± 69.4	90.45 ± 67.1	131.51 ± 240.7	79.72 ± 28.8	134.11 ± 51.9	40.41 ± 3.7
CL Hx-DR5-05 Cycle 3 Day 1 (n=5,3,2,6,2,1)	143.09 ± 50.5	140.38 ± 77.3	68.57 ± 42.2	114.74 ± 59.8	172.66 ± 78.9	41.90 ± 99999.0

No statistical analyses for this end point

Secondary: Volume of Distribution at Steady State (Vss) of Hx-DR5-01 and Hx-DR5-05

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End point title

Volume of Distribution at Steady State (Vss) of Hx-DR5-01 and Hx-DR5-05 ^[11]

End point description

The Vss of Hx-DR5-01 and Hx-DR5-05 are reported. PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. Here, 'n' denotes the number of participants evaluated for the specified time point. The arbitrary number ‘99999.0’ denotes the data for geometric coefficient of variation, which was not reached because insufficient number of participants were evaluated for the specified time point.

End point type

Secondary

End point timeframe

Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	11	7	6
Units: mL
geometric mean (geometric coefficient of variation)
Vss Hx-DR5-01 Cycle 1 Day 1 (n=8,6,4,11,7,6)	5366.8 ± 35.0	4788.6 ± 5.0	3666.8 ± 49.4	3834.6 ± 34.3	4885.9 ± 18.8	4127.3 ± 19.2
Vss Hx-DR5-01 Cycle 2 Day 1 (n=8,4,4,7,4,2)	4720.0 ± 34.9	4287.5 ± 10.5	5283.0 ± 62.0	3998.1 ± 24.0	4185.8 ± 17.3	3427.5 ± 25.1
Vss Hx-DR5-01 Cycle 3 Day 1 (n=6,4,2,6,3,1)	4622.7 ± 31.1	4531.9 ± 6.7	3243.6 ± 14.3	4075.3 ± 26.2	4227.1 ± 8.7	4118.5 ± 99999.0
Vss Hx-DR5-05 Cycle 1 Day 1 (n=8,6,4,11,6,6)	4722.7 ± 55.6	5242.9 ± 15.8	3942.4 ± 63.6	3611.0 ± 26.5	4291.6 ± 9.8	4142.9 ± 21
Vss Hx-DR5-05 Cycle 2 Day 1 (n=7,4,3,6,3,2)	4899.3 ± 22.7	4701.6 ± 15.0	5177.9 ± 100.6	4054.4 ± 16.4	4334.9 ± 14.9	3187.8 ± 41.0
Vss Hx-DR5-05 Cycle 3 Day 1 (n=5,3,2,6,2,1)	4812.5 ± 31.9	5077.6 ± 24.1	3577.1 ± 15.7	4951.2 ± 42.4	5130.8 ± 5.6	4173.9 ± 99999.0

No statistical analyses for this end point

Secondary: Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05

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End point title

Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05 ^[12]

End point description

The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported. PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. Here ‘n’ denotes the number of participants evaluated for the specified time point.

End point type

Secondary

End point timeframe

Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	11	7	6
Units: hours
median (full range (min-max))
T1/2 Hx-DR5-01 Cycle 1 Day 1 (n=8,6,4,11,7,6)	41.69 (20.7 to 61.1)	41.31 (16.6 to 60.3)	18.10 (11.4 to 40.5)	40.27 (5.1 to 66.8)	70.90 (50.5 to 86.2)	42.45 (17.9 to 80.5)
T1/2 Hx-DR5-01 Cycle 2 Day 1 (n=8,4,4,7,4,2)	37.75 (29.1 to 72.3)	39.57 (21.7 to 62.5)	24.47 (16.9 to 29.7)	49.64 (36.2 to 71.5)	33.62 (29.0 to 88.2)	65.85 (54.6 to 77.1)
T1/2 Hx-DR5-01 Cycle 3 Day 1 (n=6,4,2,6,3,1)	27.64 (16.2 to 84.1)	19.93 (13.1 to 66.9)	20.16 (16.2 to 24.1)	47.86 (30.8 to 60.0)	44.51 (40.1 to 64.0)	77.00 (77.00 to 77.00)
T1/2 Hx-DR5-05 Cycle 1 Day 1 (n=8,6,4,11,6,6)	35.55 (12.5 to 46.5)	34.50 (15.6 to 52.5)	19.10 (14.6 to 44.0)	36.33 (26.4 to 70.6)	42.68 (35.3 to 68.8)	37.71 (16.6 to 69.6)
T1/2 Hx-DR5-05 Cycle 2 Day 1 (n=7,4,3,6,3,2)	32.46 (19.3 to 71.4)	37.71 (17.3 to 80.7)	25.43 (13.9 to 62.3)	37.69 (28.4 to 43.5)	26.68 (13.1 to 29.4)	51.97 (30.8 to 73.1)
T1/2 Hx-DR5-05 Cycle 3 Day 1 (n=5,3,2,6,2,1)	25.30 (12.0 to 39.6)	18.75 (15.4 to 57.4)	41.26 (24.3 to 58.2)	33.90 (14.2 to 62.1)	22.83 (13.2 to 32.5)	70.9 (70.9 to 70.9)

No statistical analyses for this end point

Secondary: Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05

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End point title

Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05 ^[13]

End point description

The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported. PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. Here ‘n’ denotes the number of participants evaluated for the specified time point.

End point type

Secondary

End point timeframe

Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	11	7	6
Units: hours
median (full range (min-max))
Tmax Hx-DR5-01 Cycle 1 Day 1 (n=9,6,4,11,7,6)	1.58 (1.1 to 5.8)	1.89 (1.4 to 5.0)	1.23 (1.2 to 1.4)	2.00 (0.1 to 4.7)	1.30 (1.1 to 3.6)	1.46 (1.0 to 3.1)
Tmax Hx-DR5-01 Cycle 2 Day 1 (n=9,4,4,8,5,2)	1.25 (1.0 to 3.2)	3.03 (3.0 to 5.2)	1.30 (1.1 to 3.2)	3.06 (1.1 to 5.1)	3.25 (1.1 to 163.7)	1.11 (1.0 to 1.2)
Tmax Hx-DR5-01 Cycle 3 Day 1 (n=7,4,3,6,3,1)	1.08 (0.0 to 3.4)	1.48 (1.0 to 2.1)	1.13 (1.1 to 1.3)	3.08 (1.4 to 3.5)	1.82 (1.1 to 3.2)	3.1 (3.1 to 3.1)
Tmax Hx-DR5-05 Cycle 1 Day 1 (n=9,6,4,11,7,6)	1.75 (1.1 to 5.4)	2.53 (1.0 to 4.8)	2.36 (1.2 to 5.5)	1.60 (0.1 to 4.7)	1.35 (1.1 to 3.0)	1.46 (1.0 to 3.1)
Tmax Hx-DR5-05 Cycle 2 Day 1 (n=9,4,4,8,4,2)	3.12 (1.1 to 5.1)	2.19 (1.0 to 3.5)	1.19 (1.0 to 1.4)	2.26 (1.2 to 5.1)	2.31 (1.1 to 3.3)	2.21 (1.2 to 3.2)
Tmax Hx-DR5-05 Cycle 3 Day 1 (n=7,4,2,6,3,1)	1.08 (0.0 to 1.5)	1.83 (1.0 to 3.3)	1.18 (1.1 to 1.3)	1.42 (1.1 to 3.0)	1.13 (1.0 to 1.8)	3.1 (3.1 to 3.1)

No statistical analyses for this end point

Secondary: Plasma Concentration of Hx-DR5-01 and Hx-DR5-05

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End point title

Plasma Concentration of Hx-DR5-01 and Hx-DR5-05 ^[14]

End point description

The plasma concentration (PC) of Hx-DR5-01 and Hx-DR5-05 are reported. PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. Here ‘n’ denotes the number of participants evaluated for the specified time point. The arbitrary number ‘99999.0’ denotes the data for geometric coefficient of variation, which was not reached because insufficient number of participants were evaluated for the specified time point.

End point type

Secondary

End point timeframe

Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	11	7	6
Units: µg/mL
geometric mean (geometric coefficient of variation)
PC Hx-DR5-01 Cycle1 Day 1 (n=9,7,4,11,7,6)	0.085 ± 38.5	0.075 ± 0.0	0.075 ± 0.0	0.075 ± 0.0	0.075 ± 0.0	0.075 ± 0.0
PC Hx-DR5-01 Cycle2 Day 1 (n=8,7,4,8,5,2)	0.091 ± 61.0	0.075 ± 0.0	0.075 ± 0.0	0.084 ± 34.0	0.230 ± 77.8	0.283 ± 576.2
PC Hx-DR5-01 Cycle3 Day 1 (n=7,5,3,6,3,1)	0.075 ± 0.0	0.125 ± 164.3	0.075 ± 0.0	0.090 ± 46.4	0.224 ± 156.9	0.739 ± 99999.0
PC Hx-DR5-05 Cycle1 Day 1 (n=9,7,4,11,7,6)	0.094 ± 77.6	0.075 ± 0.0	0.075 ± 0.0	0.075 ± 0.0	0.075 ± 0.0	0.075 ± 0.0
PC Hx-DR5-05 Cycle2 Day 1 (n=8,7,4,8,5,2)	0.097 ± 83.6	0.075 ± 0.0	0.075 ± 0.0	0.075 ± 0.0	0.155 ± 161.5	0.240 ± 372.5
PC Hx-DR5-05 Cycle3 Day 1 (n=7,5,3,6,3,1)	0.101 ± 94.6	0.119 ± 138.5	0.075 ± 0.0	0.094 ± 58.8	0.075 ± 0.0	0.568 ± 99999.0

No statistical analyses for this end point

Secondary: Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029

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End point title

Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029 ^[15]

End point description

From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported. The Immunogenicity Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual treatment received and had at least one immunogenicity measurement taken.

End point type

Secondary

End point timeframe

From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	10	7	4	11	7	7
Units: Participants	5	5	4	7	5	0

No statistical analyses for this end point

Secondary: Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage

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End point title

Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage ^[16]

End point description

Anti-tumor activity measured by tumor shrinkage was evaluated on based on sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported. Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual treatment received.

End point type

Secondary

End point timeframe

From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	9	7	4	10	7	4
Units: millimeter
arithmetic mean (standard deviation)	12.0 ± 11.843	12.0 ± 17.616	13.75 ± 9.032	1.10 ± 9.049	9.0 ± 10.909	15.50 ± 18.574

No statistical analyses for this end point

Secondary: Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

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End point title

Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 ^[17]

End point description

The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to <10 mm of any pathological and non-pathological lymph nodes. The PR was defined as >=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion. Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to actual trial treatment received.

End point type

Secondary

End point timeframe

From Day 1 through 8.8 months (corresponding to maximum observed duration)

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	10	7	4	11	7	7
Units: Participants	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Progression-Free Survival (PFS) According to RECIST 1.1

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End point title

Progression-Free Survival (PFS) According to RECIST 1.1 ^[18]

End point description

The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and >= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The PFS was estimated using Kaplan-Meier method. Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. The arbitrary number ‘9999.0’ denotes the data for upper limit of 95% confidence interval, which was not reached because insufficient number of participants were evaluated for the specified time point.

End point type

Secondary

End point timeframe

From Day 1 through 8.8 months (corresponding to maximum observed duration)

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	10	7	4	11	7	7
Units: months
median (confidence interval 95%)	2.5 (0.5 to 3.9)	1.4 (0.5 to 9999.0)	2.4 (0.8 to 9999.0)	1.9 (1.2 to 9999.0)	1.2 (1.1 to 9999.0)	1.2 (1.0 to 9999.0)

No statistical analyses for this end point

Secondary: Overall Survival (OS) According to RECIST 1.1

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End point title

Overall Survival (OS) According to RECIST 1.1 ^[19]

End point description

Overall survival (OS) was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method. Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. The arbitrary numbers '0.999' and ‘9999.0’ denotes the data for lower limit and upper limit of 95% confidence interval, which was not reached because insufficient number of participants were evaluated for the specified time point.

End point type

Secondary

End point timeframe

From Day 1 through 8.8 months (corresponding to maximum observed duration)

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	10	7	4	11	7	7
Units: months
median (confidence interval 95%)	7.0 (2.3 to 9999.0)	6.4 (1.8 to 9999.0)	4.9 (0.999 to 9999.0)	7.1 (1.7 to 9999.0)	4.7 (2.8 to 9999.0)	6.9 (0.999 to 9999.0)

No statistical analyses for this end point

Secondary: Duration of Response (DoR) According to RECIST 1.1

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End point title

Duration of Response (DoR) According to RECIST 1.1 ^[20]

End point description

The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death. Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.

End point type

Secondary

End point timeframe

From Day 1 through 8.8 months (corresponding to maximum observed duration)

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	0 ^[21]	0 ^[22]	0 ^[23]	0 ^[24]	0 ^[25]	0 ^[26]
Units: Participants

Notes
[21] - No participants had achieved confirmed OR.
[22] - No participants had achieved confirmed OR.
[23] - No participants had achieved confirmed OR.
[24] - No participants had achieved confirmed OR.
[25] - No participants had achieved confirmed OR.
[26] - No participants had achieved confirmed OR.

No statistical analyses for this end point

Secondary: Time to Response (TTR) According to RECIST 1.1

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End point title

Time to Response (TTR) According to RECIST 1.1 ^[27]

End point description

TTR is defined as the number of days from first dose of study drug to the first documented CR or PR, which must be subsequently confirmed. Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.

End point type

Secondary

End point timeframe

From Day 1 through 8.8 months (corresponding to maximum observed duration)

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Biweekly Regimen (GEN1029 0.1 mg/ kg)	Biweekly Regimen (GEN1029 0.2 mg/kg)	Biweekly Regimen (GEN1029 0.3 mg/kg)	Biweekly Regimen (GEN1029 1.0 mg/kg)	Biweekly Regimen (GEN1029 2.0 mg/kg)	Biweekly Regimen (GEN1029 3.0 mg/kg)
Number of subjects analysed	0 ^[28]	0 ^[29]	0 ^[30]	0 ^[31]	0 ^[32]	0 ^[33]
Units: Participants

Notes
[28] - No participants had achieved confirmed OR.
[29] - No participants had achieved confirmed OR.
[30] - No participants had achieved confirmed OR.
[31] - No participants had achieved confirmed OR.
[32] - No participants had achieved confirmed OR.
[33] - No participants had achieved confirmed OR.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

For AEs: Day 1 through Day 565; and for All-cause mortality: From date of inform consent form until death

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Biweekly Regimen (GEN1029 0.1 mg/kg)

Reporting group description

Participants received 0.1 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 0.2 mg/ kg)

Reporting group description

Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 0.3 mg/ kg)

Reporting group description

Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 1.0 mg/ kg)

Reporting group description

Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 2.0 mg/ kg)

Reporting group description

Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Biweekly Regimen (GEN1029 3.0 mg/ kg)

Reporting group description

Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.

Reporting group title

Priming Regimen (GEN1029 0.1 mg/ kg)

Reporting group description

Reporting group title

Intensified Regimen (GEN1029 1.0 mg/kg)

Reporting group description

Participants received 1.0 mg/kg of GEN1029 Q1W for the first 8 weeks then Q2W until the end of treatment.

Serious adverse events	Biweekly Regimen (GEN1029 0.1 mg/kg)	Biweekly Regimen (GEN1029 0.2 mg/ kg)	Biweekly Regimen (GEN1029 0.3 mg/ kg)	Biweekly Regimen (GEN1029 1.0 mg/ kg)	Biweekly Regimen (GEN1029 2.0 mg/ kg)	Biweekly Regimen (GEN1029 3.0 mg/ kg)	Priming Regimen (GEN1029 0.1 mg/ kg)	Intensified Regimen (GEN1029 1.0 mg/kg)
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 10 (30.00%)	3 / 7 (42.86%)	2 / 4 (50.00%)	9 / 11 (81.82%)	6 / 7 (85.71%)	4 / 7 (57.14%)	0 / 1 (0.00%)	1 / 1 (100.00%)
number of deaths (all causes)	3	3	1	5	4	1	0	1
number of deaths resulting from adverse events	1	2	0	3	1	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	1 / 4 (25.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	3 / 7 (42.86%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	1 / 1	1 / 1	0 / 0	3 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aspartate aminotransferase increased
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	1 / 4 (25.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	1 / 1	1 / 1	0 / 0	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Prothrombin time prolonged
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
subjects affected / exposed	1 / 10 (10.00%)	2 / 7 (28.57%)	0 / 4 (0.00%)	3 / 11 (27.27%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 3	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 3	0 / 1	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Sinus Tachycardia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hernia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	2 / 2	0 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal Pain
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	3 / 7 (42.86%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	3 / 4	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enteritis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Large intestinal obstruction
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Drug-induced liver injury
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Lichenoid keratosis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Anal abscess
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cystitis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tinea versicolour
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypokalaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Biweekly Regimen (GEN1029 0.1 mg/kg)	Biweekly Regimen (GEN1029 0.2 mg/ kg)	Biweekly Regimen (GEN1029 0.3 mg/ kg)	Biweekly Regimen (GEN1029 1.0 mg/ kg)	Biweekly Regimen (GEN1029 2.0 mg/ kg)	Biweekly Regimen (GEN1029 3.0 mg/ kg)	Priming Regimen (GEN1029 0.1 mg/ kg)	Intensified Regimen (GEN1029 1.0 mg/kg)
Total subjects affected by non serious adverse events
subjects affected / exposed	8 / 10 (80.00%)	7 / 7 (100.00%)	4 / 4 (100.00%)	11 / 11 (100.00%)	7 / 7 (100.00%)	7 / 7 (100.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Hot flush
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0
Hypotension
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Spider vein
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	2 / 11 (18.18%)	2 / 7 (28.57%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	0	4	5	3	0	0
Chest discomfort
subjects affected / exposed	2 / 10 (20.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	2	1	0	0	0	0
Chest pain
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Chills
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	1	0	0	0
Drug withdrawal syndrome
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Early satiety
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Face oedema
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Fatigue
subjects affected / exposed	4 / 10 (40.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	5 / 11 (45.45%)	2 / 7 (28.57%)	1 / 7 (14.29%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	4	0	1	8	2	1	1	0
Mucosal inflammation
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	3 / 11 (27.27%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0
Oedema
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0
Oedema peripheral
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	2	1	0	0
Pain
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Pyrexia
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	4 / 11 (36.36%)	1 / 7 (14.29%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	0	5	1	1	0	0
Reproductive system and breast disorders
Pelvic pain
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	3	0	0	0
Dysphonia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Dyspnoea
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	1 / 11 (9.09%)	3 / 7 (42.86%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	2	0	1	3	0	0	0
Dyspnoea exertional
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Epistaxis
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Nasal congestion
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Pleuritic pain
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Insomnia
subjects affected / exposed	3 / 10 (30.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	0	0	2	0	1	0	0
Nervousness
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Investigations
Activated partial thromboplastin time prolonged
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Alanine aminotransferase increased
subjects affected / exposed	3 / 10 (30.00%)	3 / 7 (42.86%)	2 / 4 (50.00%)	6 / 11 (54.55%)	3 / 7 (42.86%)	2 / 7 (28.57%)	1 / 1 (100.00%)	1 / 1 (100.00%)
occurrences all number	5	5	5	14	3	2	2	1
Amylase increased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	4 / 10 (40.00%)	4 / 7 (57.14%)	2 / 4 (50.00%)	7 / 11 (63.64%)	4 / 7 (57.14%)	3 / 7 (42.86%)	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences all number	5	6	5	14	4	3	0	1
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	3 / 11 (27.27%)	3 / 7 (42.86%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	4	3	1	0	0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Blood creatinine increased
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	2	0	0	0	1	0	0
C-reactive protein increased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Electrocardiogram T wave inversion
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	2 / 11 (18.18%)	2 / 7 (28.57%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	2	0	0	0
Lipase increased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0
Transaminases increased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Weight decreased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0
Weight increased
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Injury, poisoning and procedural complications
Infusion related reaction
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	2 / 7 (28.57%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	3	0	0	0
Overdose
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Cardiac disorders
Tachycardia
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	0	1	1	0	0	0	1	0
Dysgeusia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0
Headache
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Paraesthesia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Somnolence
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 10 (20.00%)	2 / 7 (28.57%)	1 / 4 (25.00%)	3 / 11 (27.27%)	2 / 7 (28.57%)	1 / 7 (14.29%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	2	2	1	3	2	3	1	0
Leukocytosis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Lymphopenia
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0
Thrombocytopenia
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Eye disorders
Diplopia
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Extraocular muscle paresis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Eye pain
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Visual impairment
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Abdominal distension
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	1 / 4 (25.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	1	0	2	0	0	0
Abdominal pain
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	1	0	2	1	2	0	0
Abdominal pain upper
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	1	1	0	0
Ascites
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0
Constipation
subjects affected / exposed	4 / 10 (40.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	4	0	0	1	1	0	0	0
Diarrhoea
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	3 / 11 (27.27%)	4 / 7 (57.14%)	2 / 7 (28.57%)	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences all number	3	1	0	3	6	2	0	1
Dyspepsia
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	1	1	0	0	0
Dysphagia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0
Enteritis
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Gastrointestinal inflammation
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Gastrointestinal oedema
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	1	0	0	0
Ileus
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Melaena
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Nausea
subjects affected / exposed	2 / 10 (20.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	3 / 7 (42.86%)	1 / 7 (14.29%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	1	3	1	1	0
Paraesthesia oral
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Rectal tenesmus
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Toothache
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0
Vomiting
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	1 / 11 (9.09%)	4 / 7 (57.14%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	1	1	6	2	0	0
Hepatobiliary disorders
Biliary dilatation
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Cholangitis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Hyperbilirubinaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	1	1	2	0	0	1
Portal vein thrombosis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Skin and subcutaneous tissue disorders
Night sweats
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	1	0	0	0
Pain of skin
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Pruritus
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	2 / 11 (18.18%)	2 / 7 (28.57%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	2	0	0	0
Rash
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	2 / 11 (18.18%)	2 / 7 (28.57%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	2	1	0	0
Solar dermatitis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Bladder spasm
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Dysuria
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Haematuria
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Pollakiuria
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Proteinuria
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	3 / 11 (27.27%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	6	0	0	1	0
Back pain
subjects affected / exposed	2 / 10 (20.00%)	1 / 7 (14.29%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	1	1	0	0	0	0	0
Hypertrophic osteoarthropathy
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Joint swelling
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Musculoskeletal discomfort
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	0	0	0	0	0	1
Musculoskeletal pain
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Myalgia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0
Myopathy
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Pain in extremity
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	2	3	0	0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Cystitis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Oral candidiasis
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0
Oral herpes
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Pneumonia
subjects affected / exposed	0 / 10 (0.00%)	1 / 7 (14.29%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Rash pustular
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Trichomoniasis
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Urinary tract infection
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	2	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	2 / 10 (20.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	4 / 11 (36.36%)	3 / 7 (42.86%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	1	4	3	2	0	0
Dehydration
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	3	0	2	1	0	0	3	0
Diabetes mellitus
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Hypercalcaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0
Hyperglycaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0
Hyperkalaemia
subjects affected / exposed	1 / 10 (10.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0
Hypoalbuminaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	1 / 4 (25.00%)	2 / 11 (18.18%)	3 / 7 (42.86%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	3	4	0	0	0
Hypocalcaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Hypokalaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	4 / 7 (57.14%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	5	0	0	0
Hypomagnesaemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	1 / 11 (9.09%)	2 / 7 (28.57%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	2	1	0	0
Hyponatraemia
subjects affected / exposed	1 / 10 (10.00%)	1 / 7 (14.29%)	1 / 4 (25.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	1	0	0	2	0	0
Hypophosphataemia
subjects affected / exposed	0 / 10 (0.00%)	0 / 7 (0.00%)	0 / 4 (0.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	1	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

15 Mar 2018

Modified eligibility criteria, DLT definition, safety stopping rule, and trial objectives and trial design.

07 Feb 2019

Introduction of 2 additional dose regimens (i.e. intensified and Priming regimens) to aim to achieve the best therapeutic response.

18 Mar 2019

Introduction of a mitigation measures to prevent transaminase elevations.

13 Sep 2019

Removal of the discontinued Intensified Regimen from the protocol, modified priming regimen dose, and implementation of further precautionary measures and management guidance for mitigation of toxicities.

24 Oct 2019

Main reason for the present protocol amendment was the addition of mandatory intermediate dose levels (0.6, 2.0, 4.5, 9.0, and 15.0 mg/kg) in dose escalation, based upon health authority feedback. Other individual changes were also implemented as part of this amendment.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
15 Aug 2019	The sponsor, Genmab, notified FDA on August 9, 2019 that they are implementing a temporary halt to recruitment, based upon the observation of liver toxicity and explained the plan to permanently discontinue future development of the Intensified Regimen of GEN1029.	18 Oct 2019

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Results for the patient in Priming Regimen and the patient in Intensified Regimen (IR) were only included in the Study Report Listings. Both regimens got discontinued. The IR patient had a DLT. To avoid re-identification, listing data is not included

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Clinical trials

Clinical Trial Results: First-in-human, Open-label, Dose-escalation Trial With Expansion cohorts to Evaluate Safety of GEN1029 in Patients with Malignant Solid Tumors

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants with Dose Limiting Toxicities (DLTs)

Primary: Number of Participants with Dose Limiting Toxicities (DLTs)

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Primary: Number of Participants With >= Grade 3 Laboratory Results

Primary: Number of Participants With >= Grade 3 Laboratory Results

Secondary: Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05

Secondary: Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05

Secondary: Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05

Secondary: Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05

Secondary: Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05

Secondary: Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05

Secondary: Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05

Secondary: Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05

Secondary: Volume of Distribution at Steady State (Vss) of Hx-DR5-01 and Hx-DR5-05

Secondary: Volume of Distribution at Steady State (Vss) of Hx-DR5-01 and Hx-DR5-05

Secondary: Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05

Secondary: Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05

Secondary: Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05

Secondary: Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05

Secondary: Plasma Concentration of Hx-DR5-01 and Hx-DR5-05

Secondary: Plasma Concentration of Hx-DR5-01 and Hx-DR5-05

Secondary: Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029

Secondary: Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029

Secondary: Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage

Secondary: Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage

Secondary: Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary: Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary: Progression-Free Survival (PFS) According to RECIST 1.1

Secondary: Progression-Free Survival (PFS) According to RECIST 1.1

Secondary: Overall Survival (OS) According to RECIST 1.1

Secondary: Overall Survival (OS) According to RECIST 1.1

Secondary: Duration of Response (DoR) According to RECIST 1.1

Secondary: Duration of Response (DoR) According to RECIST 1.1

Secondary: Time to Response (TTR) According to RECIST 1.1

Secondary: Time to Response (TTR) According to RECIST 1.1

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
First-in-human, Open-label, Dose-escalation Trial With Expansion cohorts to Evaluate Safety of GEN1029 in Patients with Malignant Solid Tumors