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Clinical Trial Results:
A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

Summary
EudraCT number	2021-003569-36
Trial protocol	FR IT ES DK
Global end of trial date	04 Sep 2025

Results information
Results version number	v1(current)
This version publication date	23 Oct 2025
First version publication date	23 Oct 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

D9571C00001

ISRCTN number

US NCT number

NCT05216835

WHO universal trial number (UTN)

Other trial identifiers

EU-CT number: 2022-502773-41-00

Sponsor organisation name

AstraZeneca

Sponsor organisation address

Södertälje, Södertälje, Sweden, 151 85

Public contact

Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com

Scientific contact

Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.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

30 Aug 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

30 Aug 2024

Global end of trial reached?

Yes

Global end of trial date

04 Sep 2025

Was the trial ended prematurely?

Main objective of the trial

The main objectives of this trial were to establish the maximum tolerated dose, or optimal biological dose, and recommended Phase 2 dose in Part A; to assess the safety and tolerability of sabestomig in subjects with relapsed or refractory classical Hodgkin Lymphoma (r/rcHL) in Part A and Part B; to assess the activity of sabestomig in subjects with r/r cHL [anti-programmed cell death protein-1/programmed cell death-ligand 1 (anti-PD-1/PD-L1) exposed and naive] in Part B (B1 and B2).

Protection of trial subjects

The study was performed in accordance with ethical principles that had their origin in the Declaration of Helsinki and were consistent with ICH GCP and the AstraZeneca policy on Bioethics and Human Biological Samples.

Background therapy

Evidence for comparator

Actual start date of recruitment

18 Mar 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 5

Country: Number of subjects enrolled

Denmark: 1

Country: Number of subjects enrolled

France: 5

Country: Number of subjects enrolled

Italy: 19

Country: Number of subjects enrolled

United Kingdom: 4

Country: Number of subjects enrolled

United States: 11

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

Subjects were enrolled in this study from 18 March 2022 (First subject in) and the analyses presented in this results form are based on a final data cut-off (DCO) of 30 August 2024.

Screening details

Subjects who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment. Part B was not initiated, therefore, no subject was enrolled and analyzed for this part of the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort A1

Arm description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.

Arm type

Experimental

Investigational medicinal product name

Sabestomig

Investigational medicinal product code

AZD7789

Other name

PD-1/TIM-3 bispecific monoclonal antibody

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects were administered sabestomig 2mg once every 3 weeks (Q3W) as an intravenous (IV) infusion.

Cohort A2

Arm description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.

Arm type

Experimental

Investigational medicinal product name

Sabestomig

Investigational medicinal product code

AZD7789

Other name

PD-1/TIM-3 bispecific monoclonal antibody

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects were administered sabestomig 7mg Q3W as an IV infusion.

Cohort A3

Arm description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.

Arm type

Experimental

Investigational medicinal product name

Sabestomig

Investigational medicinal product code

AZD7789

Other name

PD-1/TIM-3 bispecific monoclonal antibody

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects were administered sabestomig 22.5mg Q3W as an IV infusion.

Cohort A4

Arm description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.

Arm type

Experimental

Investigational medicinal product name

Sabestomig

Investigational medicinal product code

AZD7789

Other name

PD-1/TIM-3 bispecific monoclonal antibody

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects were administered sabestomig 75mg Q3W as an IV infusion.

Cohort A5

Arm description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.

Arm type

Experimental

Investigational medicinal product name

Sabestomig

Investigational medicinal product code

AZD7789

Other name

PD-1/TIM-3 bispecific monoclonal antibody

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects were administered sabestomig 225mg Q3W as an IV infusion.

Cohort A6

Arm description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.

Arm type

Experimental

Investigational medicinal product name

Sabestomig

Investigational medicinal product code

AZD7789

Other name

PD-1/TIM-3 bispecific monoclonal antibody

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects were administered sabestomig 750mg Q3W as an IV infusion.

Cohort A7

Arm description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.

Arm type

Experimental

Investigational medicinal product name

Sabestomig

Investigational medicinal product code

AZD7789

Other name

PD-1/TIM-3 bispecific monoclonal antibody

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects were administered sabestomig 1500mg Q3W as an IV infusion.

Cohort A8

Arm description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.

Arm type

Experimental

Investigational medicinal product name

Sabestomig

Investigational medicinal product code

AZD7789

Other name

PD-1/TIM-3 bispecific monoclonal antibody

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Subjects were administered sabestomig 2000mg Q3W as an IV infusion.

Number of subjects in period 1	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Started	1	1	1	1	5	12	12	12
Completed	0	0	0	0	0	0	0	0
Not completed	1	1	1	1	5	12	12	12
Consent withdrawn by subject	1	-	1	-	1	-	-	1
Physician decision	-	-	-	-	-	1	1	-
Study terminated by Sponsor	-	-	-	-	-	-	-	1
Other	-	1	-	-	-	-	-	-
Death	-	-	-	1	1	1	1	1
Ongoing as of DCO (30 Aug 2024)	-	-	-	-	3	10	10	9

Baseline characteristics

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Reporting group title

Cohort A1

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.

Reporting group title

Cohort A2

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.

Reporting group title

Cohort A3

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.

Reporting group title

Cohort A4

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.

Reporting group title

Cohort A5

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.

Reporting group title

Cohort A6

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.

Reporting group title

Cohort A7

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.

Reporting group title

Cohort A8

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.

Reporting group values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8	Total
Number of subjects	1	1	1	1	5	12	12	12	45
Age categorical
Full analysis set included all subjects who received any amount of study intervention
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)	1	1	1	1	4	10	11	8	37
From 65-84 years	0	0	0	0	1	2	1	4	8
85 years and over	0	0	0	0	0	0	0	0	0
Age Continuous
Full analysis set included all subjects who received any amount of study intervention. Here, for arms with a single subject, 0.999 indicates that mean data were not reported to maintain subject's confidentiality while 0.9999 indicates that standard deviation was not calculable for a single subject.
Units: years
arithmetic mean (standard deviation)	0.999 ( 0.9999 )	0.999 ( 0.9999 )	0.999 ( 0.9999 )	0.999 ( 0.9999 )	45.8 ( 17.6 )	44.4 ( 16.0 )	38.6 ( 14.5 )	52.1 ( 21.2 )	-
Sex: Female, Male
Full analysis set included all subjects who received any amount of study intervention. For single subject in a particular gender, the data was not reported under specific category, rather a customized option was used, and the data was reported as 'All' to maintain subject's confidentiality.
Units: Subjects
Female	0	0	0	0	3	3	2	6	14
Male	0	0	0	0	2	9	10	6	27
All	1	1	1	1	0	0	0	0	4
Race/Ethnicity, Customized
Full analysis set included all subjects who received any amount of study intervention. For single subject in a particular ethnicity, the data was not reported under specific category, rather a customized option was used, and the data was reported as 'Other' to maintain subject's confidentiality.
Units: Subjects
Hispanic or Latino	0	0	0	0	0	0	0	0	0
Not Hispanic or Latino	0	0	0	0	3	12	10	10	35
Missing	0	0	0	0	2	0	1	2	5
Other	1	1	1	1	0	0	1	0	5

End points

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Reporting group title

Cohort A1

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.

Reporting group title

Cohort A2

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.

Reporting group title

Cohort A3

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.

Reporting group title

Cohort A4

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.

Reporting group title

Cohort A5

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.

Reporting group title

Cohort A6

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.

Reporting group title

Cohort A7

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.

Reporting group title

Cohort A8

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.

Subject analysis set title

Part B

Subject analysis set type

Per protocol

Subject analysis set description

Subjects with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined. Part B was not initiated, therefore, no subject was enrolled and analyzed for this analysis set. The total number of subjects enrolled for this study have been included for now to remove the validation error.

Primary: Part A (Dose Escalation): Number of subjects with adverse events (AEs)

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End point title

Part A (Dose Escalation): Number of subjects with adverse events (AEs) ^[1]

End point description

The safety and tolerability of sabestomig in subjects with r/r cHL were assessed. Safety set included all subjects who received any amount of study intervention. CTCAE = Common Terminology Criteria for Adverse Events (version 5.0); Immune-mediated AE = imAE; discontinuation = disc; including = incl. [a] = As assessed by the investigator. [b] = AE of special interest derivations were programmed based on sponsor assessment of AE terms.

End point type

Primary

End point timeframe

From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)

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 analysis was performed for this endpoint.

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	12	12	12
Units: Subjects
AE	1	1	1	1	4	12	10	12
AE possibly related to (prt) Sabestomig [a]	0	1	0	1	3	10	8	6
AE of CTCAE grade 3 (G3) or higher	0	0	0	0	1	4	2	2
AE of CTCAE G3 or higher, prt Sabestomig [a]	0	0	0	0	0	2	1	1
AE with outcome = death (OD)	0	0	0	0	1	0	0	0
AE with OD, prt Sabestomig [a]	0	0	0	0	0	0	0	0
SAE (incl. events with OD)	0	0	0	0	3	2	2	0
SAE (incl. events with OD), prt Sabestomig [a]	0	0	0	0	2	2	0	0
SAE causing disc of Sabestomig	0	0	0	0	1	0	0	0
SAE causing disc of Sabestomig, prt Sabestomig [a]	0	0	0	0	0	0	0	0
AE causing disc of Sabestomig	0	0	0	0	1	1	0	1
AE causing disc of Sabestomig, prt Sabestomig [a]	0	0	0	0	0	1	0	1
AE causing cycle delay	0	0	0	0	0	5	4	3
AE causing cycle delay, prt Sabestomig [a]	0	0	0	0	0	2	1	0
AE of special interest (AESI) [b]	0	1	0	1	2	8	7	5
AESI [b] also considered as imAE [a]	0	0	0	0	0	3	2	2
AESI [b], prt Sabestomig [a]	0	1	0	1	2	6	4	2
AESI [b] also an imAE, prt Sabestomig [a]	0	0	0	0	0	3	2	2
imAE [a]	0	0	0	0	0	3	2	3
imAE, prt Sabestomig [a]	0	0	0	0	0	3	2	3

No statistical analyses for this end point

Primary: Part A (Dose Escalation): Number of subjects with dose-limiting toxicities (DLTs)

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End point title

Part A (Dose Escalation): Number of subjects with dose-limiting toxicities (DLTs) ^[2]

End point description

DLT was defined as any ≥Grade 3 AE as per NCI CTCAE version 5 unless unequivocally due to underlying malignancy or an extraneous cause. The following conditions were considered as DLTs: • Any death not clearly due to the underlying disease or extraneous causes • Grade 4 imAE or anemia • Any ≥Grade 3 non-infectious pneumonitis or colitis of any duration • Specific liver transaminase elevation as per protocol • Any Grade 3 imAE, including rash, pruritus, or diarrhea, that does not downgrade to Grade 2 or less within 7 days • Grade 3 nausea, vomiting, or diarrhea that does not resolve to Grade 2 or less within 3 days of getting maximal supportive care • ≥Grade 3 neutropenia, without fever or systemic infection, that does not improve by at least one grade within 7 days • Grade 4 thrombocytopenia for more than 7 days or ≥Grade 3 thrombocytopenia along with Grade ≥2 bleeding • Grade 4 Cytokine Release Syndrome (CRS) of any duration or Grade 3 CRS not improving to Grade ≤2 within 72 hours

End point type

Primary

End point timeframe

From first dose [C1D1 (each cycle was 28 days)] until 28 days for each subject (within 28 days DLT period)

Notes
[2] - 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 analysis was performed for this endpoint.

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	11	12	12
Units: Subjects	0	0	0	0	1	0	0	0

No statistical analyses for this end point

Primary: Part B (Dose Expansion): Cohort B2: Complete response rate (CRR)

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End point title

Part B (Dose Expansion): Cohort B2: Complete response rate (CRR) ^[3]

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was planned to be assessed. The CRR was defined as the percentage of subjects with a CR as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of subjects in the response evaluable analysis set. Disease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).

End point type

Primary

End point timeframe

Up to approximately 2 years 90 days

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: Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint. Hence, no statistical analysis was performed.

End point values	Part B
Number of subjects analysed	0 ^[4]
Units: Percentage of Subjects
number (confidence interval 95%)	( to )

Notes
[4] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Primary: Part B (Dose Expansion): Cohort B1: Objective response rate (ORR)

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End point title

Part B (Dose Expansion): Cohort B1: Objective response rate (ORR) ^[5]

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was planned to be assessed. ORR was defined as the percentage of subjects with an objective response [Best Overall Response of a complete response (CR) or partial response (PR)] as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of subjects in the response-evaluable analysis set. Disease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).

End point type

Primary

End point timeframe

Up to approximately 2 years 90 days

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: Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint. Hence, no statistical analysis was performed.

End point values	Part B
Number of subjects analysed	0 ^[6]
Units: Percentage of Subjects
number (confidence interval 95%)	( to )

Notes
[6] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Primary: Part B (Dose Expansion): Number of subjects with AEs

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End point title

Part B (Dose Expansion): Number of subjects with AEs ^[7]

End point description

The safety and tolerability of sabestomig in subjects with r/r cHL was planned to be assessed.

End point type

Primary

End point timeframe

Up to approximately 2 years 90 days

Notes
[7] - 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: Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint. Hence, no statistical analysis was performed.

End point values	Part B
Number of subjects analysed	0 ^[8]
Units: Subjects

Notes
[8] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Complete Response Rate (CRR)

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End point title

Part A (Dose Escalation): Complete Response Rate (CRR)

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was assessed. The CRR was defined as the percentage of subjects with a CR as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, with the denominator defined as the number of subjects in the response-evaluable analysis set. Response-evaluable set included all dosed subjects who had measurable disease at baseline. Here, '9999' indicates that data were not analyzed due to presence of single subject during analysis as pre-specified in Statistical analysis plan (SAP).

End point type

Secondary

End point timeframe

From start of treatment [C1D1 (each cycle was 28 days)] until first documented disease progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	12	12	12
Units: Percentage of subjects
number (not applicable)	9999	9999	9999	9999	0	33.3	0	0

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Objective Response Rate (ORR)

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End point title

Part A (Dose Escalation): Objective Response Rate (ORR)

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was assessed. The ORR was defined as the percentage of subjects with an objective response (Best Overall Response of CR or PR) as per modified Lugano criteria (Lugano 2014), as assessed by the Investigator, with the denominator defined as the number of subjects in the response-evaluable analysis set. Response-evaluable set included all dosed subjects who had measurable disease at baseline. Here, '9999' indicates that data were not analyzed due to presence of single subject for analysis as pre-specified in SAP while '-9999.9' and '9999.9' indicate that the confidence interval data was not calculable.

End point type

Secondary

End point timeframe

From start of treatment [C1D1 (each cycle was 28 days)] until first documented disease progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	12	12	12
Units: Percentage of subjects
number (confidence interval 95%)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	0 (-9999.9 to 9999.9)	50.0 (21.1 to 78.9)	25.0 (5.5 to 57.2)	16.7 (2.1 to 48.4)

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Duration of Response (DoR)

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End point title

Part A (Dose Escalation): Duration of Response (DoR)

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was assessed. The DoR was defined as the time from the date of first documented objective response (CR or PR), as assessed by Investigator, using the modified Lugano criteria (Lugano 2014), until the date of first documented disease progression or death (by any cause in the absence of disease progression). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014). Response-evaluable set included all dosed subjects who had measurable disease at baseline. Number of subjects analyzed were number of subjects with objective response. Here, '9999' indicates that data were not analyzed due to presence of single subject for analysis as pre-specified in SAP while '-9999.9' and '9999.9' indicate that the available data did not cross the 50% probability of DoR.

End point type

Secondary

End point timeframe

From first documented response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	0 ^[9]	6	3	2
Units: Months
median (confidence interval 95%)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	( to )	9999.9 (2.7 to 9999.9)	7.7 (7.1 to 9999.9)	6.3 (-9999.9 to 9999.9)

Notes
[9] - There was no subject with objective response at the time of analysis.

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Duration of Complete Response (DoCR)

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End point title

Part A (Dose Escalation): Duration of Complete Response (DoCR)

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was assessed. The DoCR was defined as the time from first documented CR, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, until the date of first documented relapse/progression or death due to any cause (in the absence of disease progression). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014). Response-evaluable set included all dosed subjects who had measurable disease at baseline. Number of subjects analyzed were number of subjects with complete response. Here, '9999' indicates that data (DOCR) was not calculable due to low number of responders with CR events, as pre-specified in SAP.

End point type

Secondary

End point timeframe

From first documented complete response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	0 ^[10]	0 ^[11]	0 ^[12]	0 ^[13]	0 ^[14]	4	0 ^[15]	0 ^[16]
Units: Months
median (confidence interval 95%)	( to )	( to )	( to )	( to )	( to )	9999 (9999 to 9999)	( to )	( to )

Notes
[10] - The DoCR was not assessed due to low number of CR events.
[11] - The DoCR was not assessed due to low number of CR events.
[12] - The DoCR was not assessed due to low number of CR events.
[13] - The DoCR was not assessed due to low number of CR events.
[14] - The DoCR was not assessed due to low number of CR events.
[15] - The DoCR was not assessed due to low number of CR events.
[16] - The DoCR was not assessed due to low number of CR events.

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Progression-free Survival (PFS)

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End point title

Part A (Dose Escalation): Progression-free Survival (PFS)

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was assessed. PFS was defined as the time from first dose until the earlier of the date of first documented disease progression, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, or death (by any cause in the absence of disease progression or subsequent anticancer treatment). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014). Full analysis set included all subjects who received any amount of study intervention. Here, '9999' indicates that data were not analyzed due to presence of single subject for analysis as pre-specified in SAP while '9999.9' indicates that the available data did not cross the 50% probability of PFS.

End point type

Secondary

End point timeframe

From start of treatment [C1D1 (each cycle was 28 days)] until date of first documented disease progression or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	12	12	12
Units: Months
median (confidence interval 95%)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	1.9 (1.4 to 9999.9)	4.8 (2.4 to 11.9)	5.7 (1.8 to 9999.9)	2.1 (1.6 to 8.1)

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Overall Survival (OS)

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End point title

Part A (Dose Escalation): Overall Survival (OS)

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was assessed. The OS was defined as the time from the start of treatment until death due to any cause regardless of whether subject withdraws from treatment or receives another anti-lymphoma therapy. Full analysis set included all subjects who received any amount of study intervention. Here, '9999' indicates that data were not analyzed due to presence of single subject for analysis as pre-specified in SAP while '9999.9' indicates that the available data did not cross the 50% probability of OS.

End point type

Secondary

End point timeframe

From start of treatment [ClDl (each cycle was 28 days)] until date of death due to any cause or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	12	12	12
Units: Months
median (confidence interval 95%)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999 (9999 to 9999)	9999.9 (1.4 to 9999.9)	9999.9 (9999.9 to 9999.9)	9999.9 (9999.9 to 9999.9)	9999.9 (8.4 to 9999.9)

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Number of subjects with positive anti-drug antibodies (ADA) against sabestomig in serum

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End point title

Part A (Dose Escalation): Number of subjects with positive anti-drug antibodies (ADA) against sabestomig in serum

End point description

The presence of ADA for sabestomig in treated subjects with r/r cHL was assessed. Immunogenicity analysis set included all subjects who received at least 1 dose of study intervention with at least 1 reportable immunogenicity measurement.

End point type

Secondary

End point timeframe

On C1D1, C2D1, and until end of study [up to 2 years 5 months (each cycle was 28 days)]

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	12	12	12
Units: Subjects
ADA prevalence	1	0	0	0	3	4	4	2
Treatment-induced ADA positive (+)	1	0	0	0	3	4	3	2
Treatment-boosted ADA	1	0	0	0	3	3	4	2
ADA incidence	1	0	0	0	3	4	4	2
ADA + at baseline and at least one post-baseline	0	0	0	0	0	0	1	0
ADA + at baseline and not + at post-baseline	0	0	0	0	0	0	0	0
ADA transient +	0	0	0	0	1	2	2	0
ADA persistently +	1	0	0	0	2	2	1	2

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Maximum observed concentration (Cmax)

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End point title

Part A (Dose Escalation): Maximum observed concentration (Cmax)

End point description

The Cmax of sabestomig in subjects with r/r cHL was assessed. Pharmacokinetic (PK) set included all subjects who received at least 1 dose of study intervention with at least 1 reportable concentration. For Cohorts A1 to A4, median was not calculated for a single subject as pre-specified in the SAP. To resolve the validation error, the median is reported with the same value as min-max.

End point type

Secondary

End point timeframe

From C1D1 [before start of infusion (SOI) and at end of infusion (EOI)] to end of study [up to 2 years 5 months (each cycle was 28 days)]

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	12	11	11
Units: microgram (ug)/milliliter (mL)
median (full range (min-max))	0.14 (0.14 to 0.14)	1.41 (1.41 to 1.41)	5.80 (5.80 to 5.80)	15.40 (15.40 to 15.40)	52.49 (39.60 to 82.90)	256.00 (172.00 to 430.00)	516.00 (364.00 to 1480.00)	695.10 (323.00 to 1400.00)

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Area under the concentration-time curve (AUC)

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End point title

Part A (Dose Escalation): Area under the concentration-time curve (AUC)

End point description

The AUC of sabestomig in subjects with r/r cHL was assessed. PK set included all subjects who received at least 1 dose of study intervention with at least 1 reportable concentration. For Cohorts A2 to A4, median was not calculated for a single subject as pre-specified in the SAP. To resolve the validation error, the median is reported with the same value as min-max.

End point type

Secondary

End point timeframe

From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	0 ^[17]	1	1	1	5	11	11	11
Units: Day*ug/mL
median (full range (min-max))	( to )	4.24 (4.24 to 4.24)	28.50 (28.50 to 28.50)	88.80 (88.80 to 88.80)	273.00 (110.00 to 518.00)	2256.00 (1710.00 to 4780.00)	4687.00 (2740.00 to 8370.00)	6883.00 (2560.00 to 8120.00)

Notes
[17] - There was no subject with reportable data at the time of analysis.

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Clearance (CL)

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End point title

Part A (Dose Escalation): Clearance (CL)

End point description

The CL of sabestomig in subjects with r/r cHL was assessed. PK set included all subjects who received at least 1 dose of study intervention with at least 1 reportable concentration. For Cohorts A2 to A4, median was not calculated for a single subject as pre-specified in the SAP. To resolve the validation error, the median is reported with the same value as min-max.

End point type

Secondary

End point timeframe

From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	0 ^[18]	1	1	1	4	11	9	11
Units: Liter (L)/Day
median (full range (min-max))	( to )	1.3200 (1.3200 to 1.3200)	0.7210 (0.7210 to 0.7210)	0.8160 (0.8160 to 0.8160)	0.4925 (0.2910 to 1.9800)	0.2321 (0.1030 to 0.4200)	0.2211 (0.1010 to 0.3180)	0.2149 (0.1280 to 0.7020)

Notes
[18] - There was no subject with reportable data at the time of analysis.

No statistical analyses for this end point

Secondary: Part A (Dose Escalation): Terminal elimination half-life (t½λz)

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End point title

Part A (Dose Escalation): Terminal elimination half-life (t½λz)

End point description

The t½λz of sabestomig in subjects with r/r cHL was assessed. PK set included all subjects who received at least 1 dose of study intervention with at least 1 reportable concentration. For Cohorts A2 to A4, median was not calculated for a single subject as pre-specified in the SAP. To resolve the validation error, the median is reported with the same value as min-max.

End point type

Secondary

End point timeframe

From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	0 ^[19]	1	1	1	4	11	9	11
Units: Day
median (full range (min-max))	( to )	2.880 (2.880 to 2.880)	8.980 (8.980 to 8.980)	4.730 (4.730 to 4.730)	9.136 (3.100 to 25.000)	12.720 (6.680 to 42.800)	16.440 (11.200 to 22.600)	12.070 (5.990 to 21.000)

Notes
[19] - There was no subject with reportable data at the time of analysis.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Duration of Response (DoR)

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End point title

Part B (Dose Expansion): Duration of Response (DoR)

End point description

The DoR of sabestomig in subjects with r/r cHL was planned to be assessed. However, Part B was not initiated, hence data for DoR was not collected and analyzed.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[20]
Units: Months
median (confidence interval 95%)	( to )

Notes
[20] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Duration of Complete Response (DoCR)

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End point title

Part B (Dose Expansion): Duration of Complete Response (DoCR)

End point description

The DoCR of sabestomig in subjects with r/r cHL was planned to be assessed. However, Part B was not initiated, hence data for DoCR was not collected and analyzed.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[21]
Units: Months
median (confidence interval 95%)	( to )

Notes
[21] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Progression-free Survival (PFS)

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End point title

Part B (Dose Expansion): Progression-free Survival (PFS)

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was planned to be assessed. However, Part B was not initiated, hence data for PFS was not collected and analyzed.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[22]
Units: Months
median (confidence interval 95%)	( to )

Notes
[22] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Overall Survival (OS)

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End point title

Part B (Dose Expansion): Overall Survival (OS)

End point description

The anti-tumor activity of sabestomig in subjects with r/r cHL was planned to be assessed. However, Part B was not initiated, hence data for OS was not collected and analyzed.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[23]
Units: Months
median (confidence interval 95%)	( to )

Notes
[23] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Terminal elimination half-life (t½λz)

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End point title

Part B (Dose Expansion): Terminal elimination half-life (t½λz)

End point description

The t½λz of sabestomig in subjects with r/r cHL was planned to be assessed. However, Part B was not initiated, hence data for t½λz was not collected and analyzed.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[24]
Units: Day
median (full range (min-max))	( to )

Notes
[24] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Maximum observed concentration (Cmax)

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End point title

Part B (Dose Expansion): Maximum observed concentration (Cmax)

End point description

The Cmax of sabestomig in subjects with r/r cHL was planned to be assessed. However, Part B was not initiated, hence data for Cmax was not collected and analyzed.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[25]
Units: ug/mL
median (full range (min-max))	( to )

Notes
[25] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Area under the concentration-time curve (AUC)

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End point title

Part B (Dose Expansion): Area under the concentration-time curve (AUC)

End point description

The AUC of sabestomig in subjects with r/r cHL was planned to be assessed. However, Part B was not initiated, hence data for AUC was not collected and analyzed.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[26]
Units: Day*ug/mL
geometric mean (geometric coefficient of variation)	( )

Notes
[26] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Number of subjects with positive ADA against sabestomig in serum

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End point title

Part B (Dose Expansion): Number of subjects with positive ADA against sabestomig in serum

End point description

The presence of ADA for sabestomig in treated subjects with r/r cHL was planned to be assessed. However, Part B was not initiated, hence data for presence of ADA was not collected and analyzed.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[27]
Units: Subjects

Notes
[27] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE)

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End point title

Part B (Dose Expansion): Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE)

End point description

Proportion of subjects reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on peds-PRO-CTCAE was planned to be evaluated. The pediatric module included 130 items representing 62 symptomatic toxicities and permitted self-reporting by children and adolescents aged 7 to 17 years. In this study, 17 symptomatic toxicities were planned for selection. Thus, the total number of questions that subjects would have answered ranged from 17 (assuming that no branching questions were triggered, ie, the subject answered ‘0’ to the initial question for each symptom) to 42 items (assuming that all possible branching questions were triggered for every symptom posed to the subject).

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[28]
Units: Score on a scale

Notes
[28] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

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End point title

Part B (Dose Expansion): Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

End point description

Proportion of subjects reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on PRO-CTCAE was planned to be evaluated. PRO-CTCAE was a PRO measurement system developed to evaluate symptomatic toxicity in subjects on cancer clinical trials. The PRO-CTCAE Item Library included 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items were planned to evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE was planned to be assessed by 1 to 3 attributes. Conditional branching logic was planned to be used with electronic data capture, thereby reducing respondent burden. The recall period was planned as the past 7 days and PRO-CTCAE responses were planned to score from 0 to 4 (or 0/1 for absent/present).

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[29]
Units: Score on a scale

Notes
[29] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)

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End point title

Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)

End point description

Proportion of subjects reporting different levels of overall side-effect bother over time based on the PGI-TT was planned to be evaluated. For adult subjects only, the PGI-TT item was included to assess how a subject perceived the overall burden of treatment-related side effects of cancer treatment over the past 7 days. Subjects were planned to be asked to choose the response that best described the level of burden by the side effect of their cancer treatment over the past week. The planned response options were: “not at all”, “a little bit”, “somewhat”, “quite a bit”, and “very much”.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[30]
Units: Score on a scale

Notes
[30] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Secondary: Part B (Dose Expansion): European Organization for Research and Treatment of Cancer (EORTC) Item List (IL)XX QL2 [2-item global health-related quality of life (HRQoL)]

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End point title

Part B (Dose Expansion): European Organization for Research and Treatment of Cancer (EORTC) Item List (IL)XX QL2 [2-item global health-related quality of life (HRQoL)]

End point description

Proportion of subjects reporting different levels of quality of life/health over time based on the European Organization for Research and Treatment of Cancer Item List (EORTC) ILXX QL2 items was planned to be evaluated. The EORTC QLQ-C30 was a 30-item self-administered questionnaire designed for all cancer types. Questions were grouped into 5 multi-item functional scales (physical, role, emotional, cognitive, and social), 3 multi-item symptom scales (fatigue, pain, and nausea/vomiting), a 2-item global HRQoL (QL2) scale, 5 single items assessing additional symptoms commonly reported by subjects with cancer (dyspnea, loss of appetite, insomnia, constipation, and diarrhea), and 1 item on the financial impact of the disease. Subjects were planned to answer the QLQ-C30 questions in reference to how they had been over the past week. Final scores were planned to transform to range from 0 to 100, where higher scores indicated better functioning, better HRQoL, or greater level of symptoms.

End point type

Secondary

End point timeframe

Up to approximately 2 years 90 days

End point values	Part B
Number of subjects analysed	0 ^[31]
Units: Score on a scale

Notes
[31] - Part B was not initiated, therefore, no subject was enrolled and analyzed for this endpoint.

No statistical analyses for this end point

Other pre-specified: Part A (Dose Escalation): Number of subjects with adverse events of special interest (AESIs)

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End point title

Part A (Dose Escalation): Number of subjects with adverse events of special interest (AESIs)

End point description

The safety and tolerability of sabestomig in subjects with r/r cHL were assessed. An AESI was an AE of scientific and medical interest specific to understanding of a study intervention and may have required close monitoring and rapid communication to AstraZeneca by the Investigator. The AESIs for sabestomig include events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy. Safety set included all subjects who received any amount of study intervention. AE of special interest derivations were programmed based on sponsor assessment of AE terms.

End point type

Other pre-specified

End point timeframe

From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)

End point values	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Number of subjects analysed	1	1	1	1	5	12	12	12
Units: Subjects	0	1	0	1	2	8	7	5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)

Adverse event reporting additional description

Safety set included all subjects who received any amount of study intervention.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

27.0

Reporting group title

Cohort A1

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.

Reporting group title

Cohort A2

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.

Reporting group title

Cohort A3

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.

Reporting group title

Cohort A4

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.

Reporting group title

Cohort A5

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.

Reporting group title

Cohort A6

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.

Reporting group title

Cohort A7

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.

Reporting group title

Cohort A8

Reporting group description

Subjects with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.

Serious adverse events	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	3 / 5 (60.00%)	3 / 12 (25.00%)	4 / 12 (33.33%)	2 / 12 (16.67%)
number of deaths (all causes)	0	0	0	1	1	1	1	1
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Infusion related reaction
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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
Nervous system disorders
Post herpetic neuralgia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (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
Blood and lymphatic system disorders
Febrile neutropenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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	0 / 0	0 / 0
Immune system disorders
Cytokine release syndrome
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 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
Gastric perforation
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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	0 / 0	0 / 1
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (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
Musculoskeletal and connective tissue disorders
Exertional rhabdomyolysis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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	0 / 0	0 / 0
Infections and infestations
Herpes zoster
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (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
Ophthalmic herpes zoster
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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	0 / 1	0 / 0
Sepsis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (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 / 1	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	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	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Total subjects affected by non serious adverse events
subjects affected / exposed	1 / 1 (100.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	4 / 5 (80.00%)	12 / 12 (100.00%)	10 / 12 (83.33%)	12 / 12 (100.00%)
Vascular disorders
Hypotension
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	1	0	1
Hypertension
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	1	2	0	1
Chills
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	2	0
Device related thrombosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Fatigue
subjects affected / exposed	0 / 1 (0.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	3 / 12 (25.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)
occurrences all number	0	1	1	0	0	3	2	2
Oedema peripheral
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Peripheral swelling
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Pyrexia
subjects affected / exposed	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	1	0	0	0	3	1	1
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Acute graft versus host disease in skin
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Reproductive system and breast disorders
Vaginal discharge
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Vulvovaginal pruritus
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Dyspnoea
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0
Lower respiratory tract inflammation
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Nasal congestion
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	2	0
Pleural effusion
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0
Pneumonitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Rhinorrhoea
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Upper respiratory tract inflammation
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Suicidal ideation
subjects affected / exposed	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	2 / 12 (16.67%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	3	2	0
Amylase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Aspartate aminotransferase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	1	0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Blood triglycerides increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Blood thyroid stimulating hormone increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	1	1	0
C-reactive protein increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Electrocardiogram QT prolonged
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Eosinophil count increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Haemoglobin decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Lipase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	4	2	1
Neutrophil count decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	3	0
Platelet count decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	3	1
Weight decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0
Injury, poisoning and procedural complications
Arthropod bite
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Rib fracture
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Infusion related reaction
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 5 (0.00%)	3 / 12 (25.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	3	2	0
Spinal compression fracture
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Cardiac disorders
Sinus tachycardia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Sinus bradycardia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Palpitations
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Cardiomyopathy
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Cardiac failure congestive
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Atrial fibrillation
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Nervous system disorders
Peripheral sensory neuropathy
subjects affected / exposed	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0
Intention tremor
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Headache
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	2 / 12 (16.67%)	4 / 12 (33.33%)	0 / 12 (0.00%)
occurrences all number	0	0	1	0	2	2	5	0
Dizziness
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	1	0	1	1	0
Post herpetic neuralgia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Sciatica
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Tremor
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Secondary cerebellar degeneration
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	2 / 12 (16.67%)	2 / 12 (16.67%)	2 / 12 (16.67%)
occurrences all number	0	0	0	0	1	2	3	2
Lymphopenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Thrombocytopenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	1	0	1
Neutropenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Ear and labyrinth disorders
Middle ear effusion
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Vertigo
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Eye disorders
Vision blurred
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Retinopathy
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	1	1	0
Dyspepsia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	1	0
Abdominal pain upper
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Colitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Constipation
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Diarrhoea
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	3 / 12 (25.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	3	3	2
Dry mouth
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Vomiting
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	1	1
Stomatitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	3 / 12 (25.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0
Nausea
subjects affected / exposed	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	1	0	0	0	5	1	0
Haemorrhoids
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	2
Hepatobiliary disorders
Cholestasis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 5 (20.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Dermatitis acneiform
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0
Rash
subjects affected / exposed	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	2	0	0	0	1	0	0
Psoriasis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Pruritus
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)
occurrences all number	0	0	0	0	0	0	1	2
Hidradenitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Erythema
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Dry skin
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	1	1
Rash pruritic
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Rash maculo-papular
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Rash macular
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Endocrine disorders
Autoimmune thyroiditis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	1 / 5 (20.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	1 / 12 (8.33%)
occurrences all number	0	0	0	1	1	1	2	1
Arthritis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Arthralgia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Bone pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Neck pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0
Myalgia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0
Musculoskeletal pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Muscle spasms
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	2 / 12 (16.67%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	2	2	0
Flank pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	4	0	0
Periarthritis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Infections and infestations
COVID-19
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	5 / 12 (41.67%)
occurrences all number	0	0	0	0	0	2	0	5
Cystitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Device related infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Herpes zoster
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0
Gastroenteritis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Infected dermal cyst
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Otitis externa
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Nasopharyngitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)
occurrences all number	0	0	0	0	0	1	2	2
Influenza
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Pneumonia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	1	0	1
Respiratory tract infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Rhinitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)
occurrences all number	0	0	0	0	0	0	0	2
Skin infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Sinusitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Tooth abscess
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	4	0
Tracheitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Metabolism and nutrition disorders
Hypercalcaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0
Hypercholesterolaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	2	0	1
Hypertriglyceridaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	2	0	1
Dehydration
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Decreased appetite
subjects affected / exposed	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	1	0	1	0	0
Hyperuricaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Hypoalbuminaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Steroid diabetes
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0
Iron deficiency
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	0	1
Hyponatraemia
subjects affected / exposed	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0
Hypokalaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 5 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)
occurrences all number	0	0	0	0	0	0	2	1

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Were there any global substantial amendments to the protocol? Yes

24 Sep 2021

Protocol Version 2: Revisions were made for consistency and in response to request from FDA. • The stopping criteria were expanded and described in more detail. • Inclusion criterion for Part A was modified to require that subjects failed at least 2 prior lines of systemic therapy (instead of 2 prior lines of therapy) and received at least 3 cycles of anti-PD-1/PD-L1 based therapy (instead of 1 cycle). • Added text to describe dosing criteria for Cycles ≥ 2. • Added text to clarify how subjects would be monitored during and after infusions, on Cycle 1 Day 1 and for subsequent doses. • Added text to explain that the planned dose levels may need to be adjusted depending on reported AEs and DLTs. • Added text to specify that the posterior distribution for all dose levels was Beta (1+a, 1+b), where a and b are the number of subjects with and without a DLT at the current dose level, respectively. The criteria for an unsafe dose level and dose escalation/de-escalation decision rules were adjusted. • The DLT evaluation period was changed from 21 to 28 days from the first dose of AZD7789 on Cycle 1 Day 1. The definition for an evaluable subject was aligned with revised definition of the DLT evaluation period. • The total number of subjects to be enrolled in the study and the number of subjects to be enrolled in Part B were updated. • Changed the probability percentage for dose level considered to be unsafe. • It was clarified that subjects treated at the RP2D in Part A would be included in Cohort B1. • Defined No-Go and false No-Go criteria. • Added section for Cytokine Release Syndrome (CRS). • Updated conditions to be considered as DLTs: Conditions for thrombocytopenia were updated and conditions for CRS were added.

01 Nov 2022

Protocol Version 3: • Amended to clarify when a cohort (eg, Cohort A5, A6, A7 or A8) could fill their roster of up to 12 subjects independently of each other. • Reduction of PK sampling at later timepoints in Part A. Addition of AZD7789 PK and ADA samples at end of end of treatment (EoT). • The study stopping criteria were further clarified for each phase of the study by adding frequency and severity of the AEs. • Age range of subjects lowered from 18 to 16 years. Addition of text specifying that subjects between 16 and 18 years old need to provide assent, if required per local regulations, and their legally authorized representative must give signed written informed consent. Added wording associated with collecting agreement from a young adult subject or their legally authorized representative for participation in the study, and updated instances of “adult” to adult/young adult". • Amended the minimum threshold left ventricular ejection fraction as part of the inclusion criteria. • Addition of criterion for minimum body weight ≥ 40 kg for all subjects and “prior checkpoint inhibitor” to clarify which immunotherapy. • Specified for subjects with COVID-19 infection in the last 3 months, a negative PCR test would be needed within 72 hours prior to first dose. • Decreased the upper limit of the target toxicity interval from 35% to 33%. • DLT definition was amended to include Grade 4 anemia not related to the underlying disease or any extraneous cause (eg, bleeding). • A subsection was added to provide guidance in case pseudo-progression (eg, tumor flare due to immunomodulatory agent therapy) occurs during treatment with the study drug. • Added text to specify when disease progression should be reported as a SAE/ SUSAR. • Revision of the study drug discontinuation criteria in the following sections: colitis; rash/dermatitis; neurotoxicity; peripheral neuromotor syndromes; myositis; immune-mediated liver injury; cytokine release syndrome.

11 Jul 2023

Protocol Version 4: • Included objectives for quality of life / PRO assessments. • Changed eligibility of Cohort B1 from at least 3 to 2 prior cycles of anti-PD-1/ PD-L1 based therapy. • Added PRO-CTCAE (or Peds-PRO-CTCAE), PGI-TT, PROMIS PF 8c (or PROMIS Pediatric v3.0 - Mobility 7a), EORTC ILXX, PGIS, PGIC, EQ-5D-5L • Added peripheral neuropathy to the list of acceptable ongoing ≥ Grade 2 toxicities from prior therapies unless immune-mediated. • Added list of acceptable unresolved imAE ≥ Grade 2 • Modified the definition of washout period to 28 days. • Added description, preparation and administration guidance for liquid formulation.

07 May 2024

Protocol Version 5: • Added PTAP guidance including test assessments and samples at last study visit prior to the final study DCO. Added requirement for safety reporting to continue during PTAP. Clarified that the EoT visit would not be required for subjects entering the PTAP. • Revised time period for use of contraception and donation of sperm and ova to 90 days after last dose of sabestomig.

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.

Part A (dose escalation) of this study was completed and Part B (dose expansion) of this study was not initiated and therefore, data were not collected and analyzed for Part B of this study.

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Clinical trials

Clinical Trial Results: A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Part A (Dose Escalation): Number of subjects with adverse events (AEs)

Primary: Part A (Dose Escalation): Number of subjects with adverse events (AEs)

Primary: Part A (Dose Escalation): Number of subjects with dose-limiting toxicities (DLTs)

Primary: Part A (Dose Escalation): Number of subjects with dose-limiting toxicities (DLTs)

Primary: Part B (Dose Expansion): Cohort B2: Complete response rate (CRR)

Primary: Part B (Dose Expansion): Cohort B2: Complete response rate (CRR)

Primary: Part B (Dose Expansion): Cohort B1: Objective response rate (ORR)

Primary: Part B (Dose Expansion): Cohort B1: Objective response rate (ORR)

Primary: Part B (Dose Expansion): Number of subjects with AEs

Primary: Part B (Dose Expansion): Number of subjects with AEs

Secondary: Part A (Dose Escalation): Complete Response Rate (CRR)

Secondary: Part A (Dose Escalation): Complete Response Rate (CRR)

Secondary: Part A (Dose Escalation): Objective Response Rate (ORR)

Secondary: Part A (Dose Escalation): Objective Response Rate (ORR)

Secondary: Part A (Dose Escalation): Duration of Response (DoR)

Secondary: Part A (Dose Escalation): Duration of Response (DoR)

Secondary: Part A (Dose Escalation): Duration of Complete Response (DoCR)

Secondary: Part A (Dose Escalation): Duration of Complete Response (DoCR)

Secondary: Part A (Dose Escalation): Progression-free Survival (PFS)

Secondary: Part A (Dose Escalation): Progression-free Survival (PFS)

Secondary: Part A (Dose Escalation): Overall Survival (OS)

Secondary: Part A (Dose Escalation): Overall Survival (OS)

Secondary: Part A (Dose Escalation): Number of subjects with positive anti-drug antibodies (ADA) against sabestomig in serum

Secondary: Part A (Dose Escalation): Number of subjects with positive anti-drug antibodies (ADA) against sabestomig in serum

Secondary: Part A (Dose Escalation): Maximum observed concentration (Cmax)

Secondary: Part A (Dose Escalation): Maximum observed concentration (Cmax)

Secondary: Part A (Dose Escalation): Area under the concentration-time curve (AUC)

Secondary: Part A (Dose Escalation): Area under the concentration-time curve (AUC)

Secondary: Part A (Dose Escalation): Clearance (CL)

Secondary: Part A (Dose Escalation): Clearance (CL)

Secondary: Part A (Dose Escalation): Terminal elimination half-life (t½λz)

Secondary: Part A (Dose Escalation): Terminal elimination half-life (t½λz)

Secondary: Part B (Dose Expansion): Duration of Response (DoR)

Secondary: Part B (Dose Expansion): Duration of Response (DoR)

Secondary: Part B (Dose Expansion): Duration of Complete Response (DoCR)

Secondary: Part B (Dose Expansion): Duration of Complete Response (DoCR)

Secondary: Part B (Dose Expansion): Progression-free Survival (PFS)

Secondary: Part B (Dose Expansion): Progression-free Survival (PFS)

Secondary: Part B (Dose Expansion): Overall Survival (OS)

Secondary: Part B (Dose Expansion): Overall Survival (OS)

Secondary: Part B (Dose Expansion): Terminal elimination half-life (t½λz)

Secondary: Part B (Dose Expansion): Terminal elimination half-life (t½λz)

Secondary: Part B (Dose Expansion): Maximum observed concentration (Cmax)

Secondary: Part B (Dose Expansion): Maximum observed concentration (Cmax)

Secondary: Part B (Dose Expansion): Area under the concentration-time curve (AUC)

Secondary: Part B (Dose Expansion): Area under the concentration-time curve (AUC)

Secondary: Part B (Dose Expansion): Number of subjects with positive ADA against sabestomig in serum

Secondary: Part B (Dose Expansion): Number of subjects with positive ADA against sabestomig in serum

Secondary: Part B (Dose Expansion): Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE)

Secondary: Part B (Dose Expansion): Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE)

Secondary: Part B (Dose Expansion): Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Secondary: Part B (Dose Expansion): Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Secondary: Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)

Secondary: Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)

Secondary: Part B (Dose Expansion): European Organization for Research and Treatment of Cancer (EORTC) Item List (IL)XX QL2 [2-item global health-related quality of life (HRQoL)]

Secondary: Part B (Dose Expansion): European Organization for Research and Treatment of Cancer (EORTC) Item List (IL)XX QL2 [2-item global health-related quality of life (HRQoL)]

Other pre-specified: Part A (Dose Escalation): Number of subjects with adverse events of special interest (AESIs)

Other pre-specified: Part A (Dose Escalation): Number of subjects with adverse events of special interest (AESIs)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma