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Clinical Trial Results:
A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors

Summary
EudraCT number	2021-005774-25
Trial protocol	FR ES CZ BE IT HU PL
Global end of trial date	28 Nov 2024

Results information
Results version number	v1(current)
This version publication date	31 Aug 2025
First version publication date	31 Aug 2025
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

SC104 (AURELIO-04)

ISRCTN number

US NCT number

NCT05256381

WHO universal trial number (UTN)

Other trial identifiers

IND: 140011

Sponsor organisation name

SOTIO Biotech AG

Sponsor organisation address

Lichtstrasse 35 - WSJ-210, Basel, Switzerland, 4056

Public contact

Clinical trials, SOTIO Biotech AG, +420 224 175 111, clinicaltrial@sotio.com

Scientific contact

Clinical trials, SOTIO Biotech AG, +420 224 175 111, clinicaltrial@sotio.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

28 Nov 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

28 Nov 2024

Global end of trial reached?

Yes

Global end of trial date

28 Nov 2024

Was the trial ended prematurely?

Yes

Main objective of the trial

To estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab

Protection of trial subjects

Not applicable

Background therapy

Pembrolizumab 200 mg was administered as an intravenous infusion via peripheral or central venous line within 30 minutes after the first dose (day 1) of nanrilkefusp alfa in each 21-day cycle.

Evidence for comparator

Not applicable

Actual start date of recruitment

21 Jun 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Georgia: 56

Country: Number of subjects enrolled

United States: 4

Country: Number of subjects enrolled

Poland: 2

Country: Number of subjects enrolled

Spain: 45

Country: Number of subjects enrolled

Belgium: 19

Country: Number of subjects enrolled

Czechia: 8

Country: Number of subjects enrolled

France: 21

Country: Number of subjects enrolled

Hungary: 2

Country: Number of subjects enrolled

Italy: 8

Worldwide total number of subjects

165

EEA total number of subjects

105

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

Top of page

Recruitment details

Not applicable

Screening details

Forty-one investigational sites participated in study SC104 and screened at least 1 patient (8 sites in Georgia, 9 sites in Spain, 8 sites in France, 4 sites in Belgium, 3 sites in the Czech Republic, 1 site in the U.S., 5 sites in Italy, 2 sites in Hungary, 1 site in Poland).

Period 1 title

Overall (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Non-small cell lung cancer

Arm description

Advanced and/or metastatic non-small cell lung cancer (NSCLC) with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and who were not amenable to curative treatment

Arm type

Experimental

Investigational medicinal product name

Nanrilkefusp alfa

Investigational medicinal product code

SOT101

Other name

SO-C101, RLI-15

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Subcutaneous use

Dosage and administration details

Nanrilkefusp alfa 12 µg/kg was administered subcutaneously on day 1 (±1 day for the cycle start), day 2, day 8, and day 9 of each 21-day cycle.

Colorectal cancer

Arm description

Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that was unresectable or metastatic

Arm type

Experimental

Investigational medicinal product name

Nanrilkefusp alfa

Investigational medicinal product code

SOT101

Other name

SO-C101, RLI-15

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Subcutaneous use

Dosage and administration details

Nanrilkefusp alfa 12 µg/kg was administered subcutaneously on day 1 (±1 day for the cycle start), day 2, day 8, and day 9 of each 21-day cycle.

Cutaneous squamous cell carcinoma

Arm description

Recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Arm type

Experimental

Investigational medicinal product name

Nanrilkefusp alfa

Investigational medicinal product code

SOT101

Other name

SO-C101, RLI-15

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Subcutaneous use

Dosage and administration details

Nanrilkefusp alfa 12 µg/kg was administered subcutaneously on day 1 (±1 day for the cycle start), day 2, day 8, and day 9 of each 21-day cycle.

Hepatocellular carcinoma

Arm description

Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Arm type

Experimental

Investigational medicinal product name

Nanrilkefusp alfa

Investigational medicinal product code

SOT101

Other name

SO-C101, RLI-15

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Subcutaneous use

Dosage and administration details

Nanrilkefusp alfa 12 µg/kg was administered subcutaneously on day 1 (±1 day for the cycle start), day 2, day 8, and day 9 of each 21-day cycle.

Metastatic castration-resistant prostate cancer

Arm description

Treatment-refractory metastatic castration-resistant prostate cancer (mCRPC) after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Arm type

Experimental

Investigational medicinal product name

Nanrilkefusp alfa

Investigational medicinal product code

SOT101

Other name

SO-C101, RLI-15

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Subcutaneous use

Dosage and administration details

Nanrilkefusp alfa 12 µg/kg was administered subcutaneously on day 1 (±1 day for the cycle start), day 2, day 8, and day 9 of each 21-day cycle.

Ovarian cancer

Arm description

Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months

Arm type

Experimental

Investigational medicinal product name

Nanrilkefusp alfa

Investigational medicinal product code

SOT101

Other name

SO-C101, RLI-15

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Subcutaneous use

Dosage and administration details

Nanrilkefusp alfa 12 µg/kg was administered subcutaneously on day 1 (±1 day for the cycle start), day 2, day 8, and day 9 of each 21-day cycle.

Number of subjects in period 1	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Started	40	8	12	12	54	39
Completed	0	0	0	0	0	0
Not completed	40	8	12	12	54	39
Consent withdrawn by subject	4	-	2	2	8	6
Physician decision	-	-	1	-	2	-
Death	17	3	4	5	24	21
Other	-	-	-	-	1	1
Study terminated by sponsor	18	5	5	5	18	11
Lost to follow-up	1	-	-	-	1	-

Baseline characteristics

Top of page

Reporting group title

Non-small cell lung cancer

Reporting group description

Reporting group title

Colorectal cancer

Reporting group description

Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that was unresectable or metastatic

Reporting group title

Cutaneous squamous cell carcinoma

Reporting group description

Reporting group title

Hepatocellular carcinoma

Reporting group description

Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Reporting group title

Metastatic castration-resistant prostate cancer

Reporting group description

Reporting group title

Ovarian cancer

Reporting group description

Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months

Reporting group values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer	Total
Number of subjects	40	8	12	12	54	39	165
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0
Adults (18-64 years)	23	5	1	8	14	21	72
From 65-84 years	17	3	11	4	40	18	93
85 years and over	0	0	0	0	0	0	0
Age continuous
Units: years
median (standard deviation)	63.5 ( 10.43 )	59.0 ( 18.34 )	75.5 ( 10.95 )	63.5 ( 11.02 )	68.0 ( 6.57 )	64.0 ( 11.59 )	-
Gender categorical
Units: Subjects
Female	12	3	2	1	0	39	57
Male	28	5	10	11	54	0	108

Subject analysis set title

Efficacy population

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

The efficacy population consisted of all patients exposed to the combination therapy for at least one treatment cycle. This was defined as patients with 4 doses of nanrilkefusp alfa and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both nanrilkefusp alfa and pembrolizumab in Cycle 1 who started Cycle 2.

Subject analysis set title

All-subjects-as-treated population

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

The all-subjects-as-treated (ASaT) population consisted of all patients exposed to nanrilkefusp alfa or pembrolizumab.

Subject analysis sets values	Efficacy population	All-subjects-as-treated population
Number of subjects	154	165
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	67	72
From 65-84 years	87	93
85 years and over	0	0
Age continuous
Units: years
median (standard deviation)	66.0 ( 11.01 )	66.0 ( 10.90 )
Gender categorical
Units: Subjects
Female	53	57
Male	101	108

End points

Top of page

Reporting group title

Non-small cell lung cancer

Reporting group description

Reporting group title

Colorectal cancer

Reporting group description

Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that was unresectable or metastatic

Reporting group title

Cutaneous squamous cell carcinoma

Reporting group description

Reporting group title

Hepatocellular carcinoma

Reporting group description

Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Reporting group title

Metastatic castration-resistant prostate cancer

Reporting group description

Reporting group title

Ovarian cancer

Reporting group description

Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months

Subject analysis set title

Efficacy population

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

Subject analysis set title

All-subjects-as-treated population

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

The all-subjects-as-treated (ASaT) population consisted of all patients exposed to nanrilkefusp alfa or pembrolizumab.

Primary: Objective response rate according to RECIST 1.1

Top of page

End point title

Objective response rate according to RECIST 1.1 ^[1]

End point description

End point type

Primary

End point timeframe

Day 1 up to approximately 3 years

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: No statistical analyses were planned for this end point

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Percentage
number (confidence interval 95%)	5.1 (0.6 to 17.3)	33.3 (4.3 to 77.7)	27.3 (6.0 to 61.0)	0 (0 to 28.5)	10.0 (2.8 to 23.7)	11.4 (3.2 to 26.7)

No statistical analyses for this end point

Secondary: Number of patients with a treatment-emergent adverse event

Top of page

End point title

Number of patients with a treatment-emergent adverse event

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	40	8	12	12	54	39
Units: Patients	40	8	12	12	54	39

No statistical analyses for this end point

Secondary: Number of patients with an adverse event of special interest

Top of page

End point title

Number of patients with an adverse event of special interest

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	40	8	12	12	54	39
Units: Patients	0	1	0	0	0	0

No statistical analyses for this end point

Secondary: Objective response rate according to iRECIST

Top of page

End point title

Objective response rate according to iRECIST

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Percentage
number (confidence interval 95%)	7.7 (1.6 to 20.9)	33.3 (4.3 to 77.7)	36.4 (10.9 to 69.2)	0 (0 to 28.5)	12.5 (4.2 to 26.8)	11.4 (3.2 to 26.7)

No statistical analyses for this end point

Secondary: Best overall response according to RECIST 1.1: complete response

Top of page

End point title

Best overall response according to RECIST 1.1: complete response

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	0	0	1	0	0	0

No statistical analyses for this end point

Secondary: Best overall response according to RECIST 1.1: partial response

Top of page

End point title

Best overall response according to RECIST 1.1: partial response

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	2	2	2	0	4	4

No statistical analyses for this end point

Secondary: Best overall response according to RECIST 1.1: stable disease

Top of page

End point title

Best overall response according to RECIST 1.1: stable disease

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	12	3	2	5	14	4

No statistical analyses for this end point

Secondary: Best overall response according to RECIST 1.1: progressive disease

Top of page

End point title

Best overall response according to RECIST 1.1: progressive disease

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	20	1	6	5	18	23

No statistical analyses for this end point

Secondary: Best overall response according to iRECIST: complete response

Top of page

End point title

Best overall response according to iRECIST: complete response

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	0	0	1	0	0	0

No statistical analyses for this end point

Secondary: Best overall response according to iRECIST: partial response

Top of page

End point title

Best overall response according to iRECIST: partial response

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	3	2	3	0	5	4

No statistical analyses for this end point

Secondary: Best overall response according to iRECIST: stable disease

Top of page

End point title

Best overall response according to iRECIST: stable disease

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	15	3	2	5	15	4

No statistical analyses for this end point

Secondary: Best overall response according to iRECIST: unconfirmed progressive disease

Top of page

End point title

Best overall response according to iRECIST: unconfirmed progressive disease

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	13	0	3	4	14	15

No statistical analyses for this end point

Secondary: Best overall response according to iRECIST: confirmed progressive disease

Top of page

End point title

Best overall response according to iRECIST: confirmed progressive disease

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Patients	3	1	2	1	2	8

No statistical analyses for this end point

Secondary: Duration of response according to RECIST 1.1

Top of page

End point title

Duration of response according to RECIST 1.1

End point description

10: Not reached 0 or 100: Not estimable

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: months
median (confidence interval 95%)	3.6 (1.7 to 100)	10 (0 to 100)	10 (2.8 to 100)	0 (0 to 0)	10 (4.3 to 100)	3.0 (2.8 to 100)

No statistical analyses for this end point

Secondary: Duration of response according to iRECIST

Top of page

End point title

Duration of response according to iRECIST

End point description

10: Not reached 0 or 100: Not estimable

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: months
median (confidence interval 95%)	3.6 (1.7 to 100)	10 (0 to 100)	10 (2.8 to 100)	0 (0 to 0)	13.9 (4.3 to 100)	3.0 (2.8 to 100)

No statistical analyses for this end point

Secondary: Clinical benefit rate according to RECIST 1.1

Top of page

End point title

Clinical benefit rate according to RECIST 1.1

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Percentage
number (confidence interval 95%)	35.9 (21.2 to 52.8)	83.3 (35.9 to 99.6)	45.5 (16.7 to 76.6)	45.5 (16.7 to 76.6)	45.0 (29.3 to 61.5)	22.9 (10.4 to 40.1)

No statistical analyses for this end point

Secondary: Clinical benefit rate according to iRECIST

Top of page

End point title

Clinical benefit rate according to iRECIST

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: Percentage
number (confidence interval 95%)	46.2 (30.1 to 62.8)	83.3 (35.9 to 99.6)	54.5 (23.4 to 83.3)	45.5 (16.7 to 76.6)	50.0 (33.8 to 66.2)	22.9 (10.4 to 40.1)

No statistical analyses for this end point

Secondary: Progression-free survival according to RECIST 1.1

Top of page

End point title

Progression-free survival according to RECIST 1.1

End point description

10: Not reached 0 or 100: Not estimable

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: months
median (confidence interval 95%)	1.6 (1.3 to 2.8)	10 (1.1 to 100)	1.4 (1.2 to 100)	2.7 (1.1 to 4.3)	2.6 (1.4 to 6.4)	1.6 (1.4 to 2.6)

No statistical analyses for this end point

Secondary: Progression-free survival according to iRECIST

Top of page

End point title

Progression-free survival according to iRECIST

End point description

10: Not reached 0 or 100: Not estimable

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: months
median (confidence interval 95%)	3.0 (1.3 to 5.7)	10 (1.1 to 100)	4.1 (1.2 to 100)	2.7 (1.1 to 4.3)	4.6 (1.6 to 6.8)	1.6 (1.4 to 2.6)

No statistical analyses for this end point

Secondary: Time to response according to RECIST 1.1

Top of page

End point title

Time to response according to RECIST 1.1

End point description

10: Not reached 0 or 100: Not estimable

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: months
median (confidence interval 95%)	10 (0 to 100)	14.1 (1.6 to 100)	10 (1.4 to 100)	10 (0 to 100)	10 (0 to 100)	10 (6.9 to 100)

No statistical analyses for this end point

Secondary: Time to response according to iRECIST

Top of page

End point title

Time to response according to iRECIST

End point description

10: Not reached 0 or 100: Not estimable

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	6	11	11	40	35
Units: months
median (confidence interval 95%)	10 (0 to 100)	14.1 (1.6 to 100)	10 (1.4 to 100)	10 (0 to 100)	10 (0 to 100)	10 (6.9 to 100)

No statistical analyses for this end point

Secondary: Duration of response according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Top of page

End point title

Duration of response according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1 ^[2]

End point description

10: Not reached 0 or 100: Not estimable

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

Notes
[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: This endpoint is applicable only in patients with metastatic castration-resistant prostate cancer

End point values	Metastatic castration-resistant prostate cancer
Number of subjects analysed	40
Units: months
median (confidence interval 95%)	10 (4.3 to 100)

No statistical analyses for this end point

Secondary: Clinical benefit rate according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Top of page

End point title

Clinical benefit rate according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1 ^[3]

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

Notes
[3] - 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: This endpoint is applicable only in patients with metastatic castration-resistant prostate cancer

End point values	Metastatic castration-resistant prostate cancer
Number of subjects analysed	40
Units: Percentage
number (confidence interval 95%)	45.0 (29.3 to 61.5)

No statistical analyses for this end point

Secondary: Progression-free survival according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Top of page

End point title

Progression-free survival according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1 ^[4]

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 3 years

Notes
[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: This endpoint is applicable only in patients with metastatic castration-resistant prostate cancer

End point values	Metastatic castration-resistant prostate cancer
Number of subjects analysed	40
Units: months
median (confidence interval 95%)	2.6 (1.4 to 6.4)

No statistical analyses for this end point

Secondary: Circulating tumor cell count conversion as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

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End point title

Circulating tumor cell count conversion as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1 ^[5]

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 2 years

Notes
[5] - 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: This endpoint is applicable only in patients with metastatic castration-resistant prostate cancer

End point values	Metastatic castration-resistant prostate cancer
Number of subjects analysed	40
Units: Percentage
number (confidence interval 95%)	3.8 (0.5 to 13.2)

No statistical analyses for this end point

Secondary: Confirmed prostate-specific antigen decline of ≥50% as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

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End point title

Confirmed prostate-specific antigen decline of ≥50% as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1 ^[6]

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 2 years

Notes
[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: This endpoint is applicable only in patients with metastatic castration-resistant prostate cancer

End point values	Metastatic castration-resistant prostate cancer
Number of subjects analysed	40
Units: Percentage
number (confidence interval 95%)	13.5 (5.8 to 26.7)

No statistical analyses for this end point

Secondary: Time to confirmed prostate-specific antigen progression as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

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End point title

Time to confirmed prostate-specific antigen progression as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1 ^[7]

End point description

End point type

Secondary

End point timeframe

Day 1 up to approximately 2 years

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: This endpoint is applicable only in patients with metastatic castration-resistant prostate cancer

End point values	Metastatic castration-resistant prostate cancer
Number of subjects analysed	40
Units: months
median (confidence interval 95%)	2.3 (1.3 to 4.3)

No statistical analyses for this end point

Secondary: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration

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End point title

Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration

End point description

End point type

Secondary

End point timeframe

Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	37	8	12	12	53	38
Units: ng/mL
median (full range (min-max))	1.0900 (0.260 to 3.850)	0.5890 (0.487 to 4.530)	0.7200 (0.363 to 5.580)	0.9470 (0.358 to 3.460)	0 (0 to 4.370)	0.9020 (0.151 to 3.690)

No statistical analyses for this end point

Secondary: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration

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End point title

Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration

End point description

End point type

Secondary

End point timeframe

Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	37	8	12	12	53	38
Units: ng/mL
median (full range (min-max))	3.6800 (0.628 to 15.600)	3.6700 (1.220 to 11.900)	3.4250 (1.350 to 19.100)	2.5600 (0.820 to 4.070)	3.4500 (0.291 to 15.800)	3.1300 (0.288 to 10.700)

No statistical analyses for this end point

Secondary: Number of patients with anti-drug antibodies, Cycle 4 Day 1

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End point title

Number of patients with anti-drug antibodies, Cycle 4 Day 1

End point description

End point type

Secondary

End point timeframe

Cycle 4 Day 1

End point values	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Number of subjects analysed	39	8	12	12	53	39
Units: Patients	5	3	3	0	4	5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events (AEs): from study treatment start to 90 days after study treatment end or to new anti-cancer therapy start; related serious AEs: collected beyond 90 days after study treatment end; deaths: consent signature to study end

Adverse event reporting additional description

Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

Non-small cell lung cancer

Reporting group description

Reporting group title

Colorectal cancer

Reporting group description

Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that is unresectable or metastatic

Reporting group title

Cutaneous squamous cell carcinoma

Reporting group description

Recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy is not feasible

Reporting group title

Hepatocellular carcinoma

Reporting group description

Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Reporting group title

Metastatic castration-resistant prostate cancer

Reporting group description

Reporting group title

Ovarian cancer

Reporting group description

Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months

Serious adverse events	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Total subjects affected by serious adverse events
subjects affected / exposed	23 / 40 (57.50%)	3 / 8 (37.50%)	3 / 12 (25.00%)	3 / 12 (25.00%)	28 / 54 (51.85%)	28 / 39 (71.79%)
number of deaths (all causes)	17	3	4	5	24	21
number of deaths resulting from adverse events	11	2	2	1	10	12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
subjects affected / exposed	5 / 40 (12.50%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	7 / 54 (12.96%)	6 / 39 (15.38%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 1	0 / 0	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 5	0 / 0	0 / 1	0 / 0	0 / 6	0 / 6
Cancer pain
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypotension
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	1 / 1	0 / 0	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
Jugular vein thrombosis
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	2 / 40 (5.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 54 (5.56%)	8 / 39 (20.51%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 0	0 / 0	7 / 7	14 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	4 / 40 (10.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	3 / 54 (5.56%)	3 / 39 (7.69%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	1 / 1	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 0	0 / 0	1 / 1	0 / 1	0 / 2
Fatigue
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	3 / 39 (7.69%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Death
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	2 / 39 (5.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
Discomfort
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
Immune system disorders
Cytokine release syndrome
subjects affected / exposed	2 / 40 (5.00%)	1 / 8 (12.50%)	3 / 12 (25.00%)	1 / 12 (8.33%)	7 / 54 (12.96%)	7 / 39 (17.95%)
occurrences causally related to treatment / all	6 / 6	1 / 1	4 / 4	3 / 3	9 / 9	7 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumonitis
subjects affected / exposed	2 / 40 (5.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 2	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
Pulmonary embolism
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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
Interstitial lung disease
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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
Pleural effusion
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Aspartate aminotransferase increased
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 54 (0.00%)	2 / 39 (5.13%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	1 / 1	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Alanine aminotransferase increased
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	2 / 39 (5.13%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood bilirubin increased
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	1 / 1	0 / 0	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
Lymphocyte count decreased
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Infusion related reaction
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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
Cardiac disorders
Cardiac arrest
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Cardiogenic shock
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	0 / 40 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Myocarditis
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
Nervous system disorders
Cerebral haemorrhage
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Constipation
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	2 / 39 (5.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	2 / 39 (5.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Small intestinal obstruction
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	2 / 39 (5.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 54 (3.70%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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
Hepatobiliary disorders
Biliary dilatation
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Haematuria
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 54 (3.70%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 54 (3.70%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Bone pain
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 54 (3.70%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Sepsis
subjects affected / exposed	0 / 40 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 54 (3.70%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	1 / 39 (2.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Cachexia
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 54 (1.85%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	0 / 40 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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
Hypercalcaemia
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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
Hyperkalaemia
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 54 (0.00%)	0 / 39 (0.00%)
occurrences causally related to treatment / all	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

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Non-small cell lung cancer	Colorectal cancer	Cutaneous squamous cell carcinoma	Hepatocellular carcinoma	Metastatic castration-resistant prostate cancer	Ovarian cancer
Total subjects affected by non serious adverse events
subjects affected / exposed	40 / 40 (100.00%)	8 / 8 (100.00%)	12 / 12 (100.00%)	12 / 12 (100.00%)	54 / 54 (100.00%)	39 / 39 (100.00%)
Investigations
Lymphocyte count decreased
subjects affected / exposed	17 / 40 (42.50%)	5 / 8 (62.50%)	4 / 12 (33.33%)	8 / 12 (66.67%)	21 / 54 (38.89%)	7 / 39 (17.95%)
occurrences all number	26	10	10	14	42	9
Aspartate aminotransferase increased
subjects affected / exposed	15 / 40 (37.50%)	3 / 8 (37.50%)	1 / 12 (8.33%)	1 / 12 (8.33%)	16 / 54 (29.63%)	9 / 39 (23.08%)
occurrences all number	23	4	1	5	30	10
Alanine aminotransferase increased
subjects affected / exposed	14 / 40 (35.00%)	2 / 8 (25.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	14 / 54 (25.93%)	9 / 39 (23.08%)
occurrences all number	22	3	1	2	17	11
Blood bilirubin increased
subjects affected / exposed	5 / 40 (12.50%)	1 / 8 (12.50%)	0 / 12 (0.00%)	3 / 12 (25.00%)	8 / 54 (14.81%)	3 / 39 (7.69%)
occurrences all number	6	3	0	4	9	5
Neutrophil count decreased
subjects affected / exposed	1 / 40 (2.50%)	2 / 8 (25.00%)	2 / 12 (16.67%)	2 / 12 (16.67%)	10 / 54 (18.52%)	3 / 39 (7.69%)
occurrences all number	3	7	5	3	24	10
Platelet count decreased
subjects affected / exposed	3 / 40 (7.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)	11 / 54 (20.37%)	1 / 39 (2.56%)
occurrences all number	4	0	0	6	32	1
Blood creatinine increased
subjects affected / exposed	4 / 40 (10.00%)	1 / 8 (12.50%)	2 / 12 (16.67%)	1 / 12 (8.33%)	6 / 54 (11.11%)	2 / 39 (5.13%)
occurrences all number	5	2	2	4	17	6
Blood alkaline phosphatase increased
subjects affected / exposed	8 / 40 (20.00%)	1 / 8 (12.50%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 54 (3.70%)	1 / 39 (2.56%)
occurrences all number	11	1	1	1	2	1
Amylase increased
subjects affected / exposed	3 / 40 (7.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	4 / 54 (7.41%)	4 / 39 (10.26%)
occurrences all number	3	0	0	0	13	4
Weight decreased
subjects affected / exposed	5 / 40 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 54 (5.56%)	2 / 39 (5.13%)
occurrences all number	5	0	0	0	3	2
Lipase increased
subjects affected / exposed	4 / 40 (10.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 54 (5.56%)	1 / 39 (2.56%)
occurrences all number	5	1	0	0	4	1
Vascular disorders
Hypotension
subjects affected / exposed	9 / 40 (22.50%)	2 / 8 (25.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	14 / 54 (25.93%)	5 / 39 (12.82%)
occurrences all number	11	4	7	0	43	5
Hypertension
subjects affected / exposed	4 / 40 (10.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	3 / 12 (25.00%)	3 / 54 (5.56%)	4 / 39 (10.26%)
occurrences all number	4	0	2	4	4	4
Cardiac disorders
Tachycardia
subjects affected / exposed	1 / 40 (2.50%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 12 (0.00%)	4 / 54 (7.41%)	4 / 39 (10.26%)
occurrences all number	1	1	0	0	5	4
Nervous system disorders
Headache
subjects affected / exposed	6 / 40 (15.00%)	1 / 8 (12.50%)	1 / 12 (8.33%)	0 / 12 (0.00%)	5 / 54 (9.26%)	5 / 39 (12.82%)
occurrences all number	6	3	5	0	8	8
Tremor
subjects affected / exposed	4 / 40 (10.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	1 / 12 (8.33%)	8 / 54 (14.81%)	2 / 39 (5.13%)
occurrences all number	5	1	0	1	14	3
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	26 / 40 (65.00%)	4 / 8 (50.00%)	10 / 12 (83.33%)	7 / 12 (58.33%)	38 / 54 (70.37%)	36 / 39 (92.31%)
occurrences all number	114	40	30	19	161	154
Chills
subjects affected / exposed	15 / 40 (37.50%)	3 / 8 (37.50%)	3 / 12 (25.00%)	1 / 12 (8.33%)	21 / 54 (38.89%)	15 / 39 (38.46%)
occurrences all number	20	12	11	1	32	54
Fatigue
subjects affected / exposed	15 / 40 (37.50%)	1 / 8 (12.50%)	3 / 12 (25.00%)	6 / 12 (50.00%)	13 / 54 (24.07%)	14 / 39 (35.90%)
occurrences all number	16	1	4	6	20	18
Injection site reaction
subjects affected / exposed	11 / 40 (27.50%)	3 / 8 (37.50%)	2 / 12 (16.67%)	4 / 12 (33.33%)	13 / 54 (24.07%)	19 / 39 (48.72%)
occurrences all number	48	9	3	7	25	92
Asthenia
subjects affected / exposed	12 / 40 (30.00%)	1 / 8 (12.50%)	4 / 12 (33.33%)	1 / 12 (8.33%)	20 / 54 (37.04%)	13 / 39 (33.33%)
occurrences all number	12	1	6	2	25	17
Oedema peripheral
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	4 / 54 (7.41%)	4 / 39 (10.26%)
occurrences all number	1	0	0	2	4	4
Chest pain
subjects affected / exposed	5 / 40 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 54 (5.56%)	1 / 39 (2.56%)
occurrences all number	5	0	0	0	3	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	17 / 40 (42.50%)	1 / 8 (12.50%)	1 / 12 (8.33%)	3 / 12 (25.00%)	31 / 54 (57.41%)	8 / 39 (20.51%)
occurrences all number	23	1	3	4	52	9
Immune system disorders
Cytokine release syndrome
subjects affected / exposed	6 / 40 (15.00%)	2 / 8 (25.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	12 / 54 (22.22%)	2 / 39 (5.13%)
occurrences all number	23	10	4	3	38	7
Gastrointestinal disorders
Vomiting
subjects affected / exposed	11 / 40 (27.50%)	0 / 8 (0.00%)	1 / 12 (8.33%)	4 / 12 (33.33%)	17 / 54 (31.48%)	22 / 39 (56.41%)
occurrences all number	14	0	1	7	33	43
Nausea
subjects affected / exposed	10 / 40 (25.00%)	1 / 8 (12.50%)	2 / 12 (16.67%)	2 / 12 (16.67%)	13 / 54 (24.07%)	24 / 39 (61.54%)
occurrences all number	18	19	2	5	20	36
Diarrhoea
subjects affected / exposed	5 / 40 (12.50%)	1 / 8 (12.50%)	1 / 12 (8.33%)	3 / 12 (25.00%)	4 / 54 (7.41%)	12 / 39 (30.77%)
occurrences all number	8	8	1	3	5	15
Constipation
subjects affected / exposed	3 / 40 (7.50%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	4 / 54 (7.41%)	7 / 39 (17.95%)
occurrences all number	3	0	2	1	4	8
Abdominal pain
subjects affected / exposed	2 / 40 (5.00%)	1 / 8 (12.50%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 54 (0.00%)	10 / 39 (25.64%)
occurrences all number	3	1	1	1	0	10
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	7 / 40 (17.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	3 / 12 (25.00%)	1 / 54 (1.85%)	6 / 39 (15.38%)
occurrences all number	7	0	0	3	1	8
Cough
subjects affected / exposed	6 / 40 (15.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 54 (3.70%)	3 / 39 (7.69%)
occurrences all number	8	0	2	1	2	3
Endocrine disorders
Hypothyroidism
subjects affected / exposed	3 / 40 (7.50%)	1 / 8 (12.50%)	1 / 12 (8.33%)	1 / 12 (8.33%)	6 / 54 (11.11%)	3 / 39 (7.69%)
occurrences all number	4	1	1	2	6	3
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	5 / 40 (12.50%)	1 / 8 (12.50%)	1 / 12 (8.33%)	2 / 12 (16.67%)	4 / 54 (7.41%)	1 / 39 (2.56%)
occurrences all number	5	3	3	2	6	1
Back pain
subjects affected / exposed	3 / 40 (7.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	4 / 54 (7.41%)	2 / 39 (5.13%)
occurrences all number	4	0	0	1	4	2
Myalgia
subjects affected / exposed	1 / 40 (2.50%)	1 / 8 (12.50%)	1 / 12 (8.33%)	1 / 12 (8.33%)	3 / 54 (5.56%)	2 / 39 (5.13%)
occurrences all number	1	6	1	1	3	2
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	11 / 40 (27.50%)	0 / 8 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	11 / 54 (20.37%)	10 / 39 (25.64%)
occurrences all number	12	0	1	2	13	11
Hypoalbuminaemia
subjects affected / exposed	5 / 40 (12.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	6 / 54 (11.11%)	3 / 39 (7.69%)
occurrences all number	5	0	0	3	9	3
Hypocalcaemia
subjects affected / exposed	1 / 40 (2.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	12 / 54 (22.22%)	1 / 39 (2.56%)
occurrences all number	2	0	0	0	19	1
Hypokalaemia
subjects affected / exposed	7 / 40 (17.50%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	3 / 54 (5.56%)	2 / 39 (5.13%)
occurrences all number	7	0	1	0	4	2
Hypophosphataemia
subjects affected / exposed	6 / 40 (15.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	4 / 54 (7.41%)	0 / 39 (0.00%)
occurrences all number	11	0	0	0	7	0
Hypomagnesaemia
subjects affected / exposed	3 / 40 (7.50%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 54 (5.56%)	3 / 39 (7.69%)
occurrences all number	5	0	0	0	3	4

More information

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Were there any global substantial amendments to the protocol? Yes

20 Apr 2023

-Recruitment to pause during futility analyses -Benefit/risk, recommended phase 2 dose updated -Pharmacokinetics, anti-drug antibody, prostate cancer biomarker, ECG time points reduced -Time window for blood sampling added -Tumor imaging continued at clinical progression -Re-screening; echocardiography or multigated acquisition scanning; up to 3 lines of previous treatment for hepatocellular carcinoma and up to 4 lines for prostate and ovarian cancer; any -mRNA, adenoviral, or inactivated licensed COVID-19 vaccine allowed -Egg and sperm donation, nanrilkefusp alfa monotherapy in the Czech Republic not allowed -Circulating tumor cell count “>5” changed to “≥5” -Day 6 blood sampling always performed -Progression-free survival and time to response censoring at “eligibility” changed to “the first day of study treatment” -Treatment concentrations over time in serum not plasma -Fresh biopsy during screening -Exclusion criterion 3 changed to “before study treatment (cycle 1 day 1)” -Exclusion criterion 8.3 changed to “…and any clinically significant history of coronary heart disease and clinically significant artery disease within the past 5 years” -Adverse event terminology according to NCI CTCAE 5.0 - “Whole blood biomarker analysis” row in the table deleted -End of study clarified -Live/attenuated vaccines prohibited 90 days after study treatment -Serology testing mandatory -Cytokine release syndrome, shortening of the QT interval, injection site reaction, hypothyroidism and myocarditis associated with pembrolizumab, fever prevention, toxicity management -recommendations -Information about SUSAR reporting, nanrilkefusp alfa application -Instructions for reporting of certain liver adverse events -Study investigator to obtain consent from pregnant patients -Specification of populations as per national competent authorities’ or ethics committees -Biochemistry on cycle 3 day 8 -Pregnancy test until the end of contraception

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Objective response rate according to RECIST 1.1

Primary: Objective response rate according to RECIST 1.1

Secondary: Number of patients with a treatment-emergent adverse event

Secondary: Number of patients with a treatment-emergent adverse event

Secondary: Number of patients with an adverse event of special interest

Secondary: Number of patients with an adverse event of special interest

Secondary: Objective response rate according to iRECIST

Secondary: Objective response rate according to iRECIST

Secondary: Best overall response according to RECIST 1.1: complete response

Secondary: Best overall response according to RECIST 1.1: complete response

Secondary: Best overall response according to RECIST 1.1: partial response

Secondary: Best overall response according to RECIST 1.1: partial response

Secondary: Best overall response according to RECIST 1.1: stable disease

Secondary: Best overall response according to RECIST 1.1: stable disease

Secondary: Best overall response according to RECIST 1.1: progressive disease

Secondary: Best overall response according to RECIST 1.1: progressive disease

Secondary: Best overall response according to iRECIST: complete response

Secondary: Best overall response according to iRECIST: complete response

Secondary: Best overall response according to iRECIST: partial response

Secondary: Best overall response according to iRECIST: partial response

Secondary: Best overall response according to iRECIST: stable disease

Secondary: Best overall response according to iRECIST: stable disease

Secondary: Best overall response according to iRECIST: unconfirmed progressive disease

Secondary: Best overall response according to iRECIST: unconfirmed progressive disease

Secondary: Best overall response according to iRECIST: confirmed progressive disease

Secondary: Best overall response according to iRECIST: confirmed progressive disease

Secondary: Duration of response according to RECIST 1.1

Secondary: Duration of response according to RECIST 1.1

Secondary: Duration of response according to iRECIST

Secondary: Duration of response according to iRECIST

Secondary: Clinical benefit rate according to RECIST 1.1

Secondary: Clinical benefit rate according to RECIST 1.1

Secondary: Clinical benefit rate according to iRECIST

Secondary: Clinical benefit rate according to iRECIST

Secondary: Progression-free survival according to RECIST 1.1

Secondary: Progression-free survival according to RECIST 1.1

Secondary: Progression-free survival according to iRECIST

Secondary: Progression-free survival according to iRECIST

Secondary: Time to response according to RECIST 1.1

Secondary: Time to response according to RECIST 1.1

Secondary: Time to response according to iRECIST

Secondary: Time to response according to iRECIST

Secondary: Duration of response according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Duration of response according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Clinical benefit rate according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Clinical benefit rate according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Progression-free survival according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Progression-free survival according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Circulating tumor cell count conversion as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Circulating tumor cell count conversion as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Confirmed prostate-specific antigen decline of ≥50% as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Confirmed prostate-specific antigen decline of ≥50% as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Time to confirmed prostate-specific antigen progression as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Time to confirmed prostate-specific antigen progression as assessed according to Prostate Cancer Clinical Trials Working Group 3 modified RECIST 1.1

Secondary: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration

Secondary: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration

Secondary: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration

Secondary: Nanrilkefusp alfa concentration profile, Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration

Secondary: Number of patients with anti-drug antibodies, Cycle 4 Day 1

Secondary: Number of patients with anti-drug antibodies, Cycle 4 Day 1

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors