Safety and Preliminary Efficacy Assessment of AZD7789 in... | NCT05216835 | Trialant
NCT05216835
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Oct 2, 2025Actual
Enrollment
45Actual
Phase
Phase 1
Conditions
Relapsed or Refractory Classical Hodgkin Lymphoma
Interventions
Sabestomig (AZD7789)
Countries
United States
Canada
Denmark
France
Italy
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05216835
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D9571C00001
Secondary IDs
ID
Type
Description
Link
2021-003569-36
EudraCT Number
Brief Title
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Official Title
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.
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 18, 2022Actual
Primary Completion Date
Aug 30, 2024Actual
Completion Date
Sep 4, 2025Actual
First Submitted Date
Jan 19, 2022
First Submission Date that Met QC Criteria
Jan 19, 2022
First Posted Date
Feb 1, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Feb 28, 2025
Results First Submitted that Met QC Criteria
Apr 15, 2025
Results First Posted Date
May 2, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 18, 2025
Last Update Posted Date
Oct 2, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Name
Class
Parexel
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
Detailed Description
This is a Phase I/II, open-label multi-center study will have sabestomig administered via intravenous infusion on Cycle 1 Day 1 to adult/young adult patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL). This study will have 2 parts: Phase 1 (Part A) Dose Escalation and Phase 2 (Part B) Dose Expansion.
Patients will be treated with study intervention for a maximum of 35 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent, or if other reasons to discontinue treatment occur.
The trial was intended to be Phase I/II trial (but the trial never moved forward to Phase 2). Hence, the study Phase was updated to Phase I.
Conditions Module
Conditions
Relapsed or Refractory Classical Hodgkin Lymphoma
Keywords
Pharmacokinetics
Classical Hodgkin Lymphoma (cHL)
Dose Expansion
Dose escalation
r/r cHL
programmed cell death protein-1 (PD-1)
Accelerated titration design (ATD)
T cell immunoglobulin and mucin domain-containing protein-3 (TIM-3)
Modified toxicity probability interval-2 (mTPI-2)
Bispecific antibody
Immunotherapy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
45Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A: Dose Escalation
Experimental
Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig to determine the recommended phase 2 dose (RP2D).
Drug: Sabestomig (AZD7789)
Cohort B1: Dose Expansion
Experimental
Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig once the RP2D has been determined.
Drug: Sabestomig (AZD7789)
Cohort B2: Dose Expansion
Experimental
Patients with anti-PD-1/PD-L1 naïve r/r cHL will receive sabestomig once the RP2D has been determined.
Drug: Sabestomig (AZD7789)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sabestomig (AZD7789)
Drug
Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion.
Cohort A: Dose Escalation
Cohort B1: Dose Expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
The safety and tolerability of sabestomig in participants with r/r cHL were assessed.
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)
Part A (Dose Escalation): Number of Participants With Dose-limiting Toxicities (DLTs)
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
From first dose (C1D1) until 28 days for each participant [within 28 days DLT period]
Part B (Dose Expansion): Cohort B1: Objective Response Rate (ORR)
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
ORR was defined as the percentage of participants 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 participants 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).
Up to approximately 2 years 90 days
Part B (Dose Expansion): Cohort B2: Complete Response Rate (CRR)
Secondary Outcomes
Measure
Description
Time Frame
Part A (Dose Escalation): Complete Response Rate (CRR)
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.
The CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set.
Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
Other Outcomes
Measure
Description
Time Frame
Part A (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs)
The safety and tolerability of sabestomig in participants 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.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
≥ 16 years of age at the time of obtaining informed consent
Eastern Cooperative Oncology Group performance status of 0 or 1 at screening
At least one positron emission tomography (PET)-avid measurable lesion according to Modified Lugano Criteria after the last line of therapy.
Confirmed histological diagnosis of active relapse/refractory cHL
Failed at least 2 prior lines of systemic therapy.
No previous treatment with anti-TIM-3.
Adequate organ and bone marrow function
Non-pregnant women and willingness of female patients to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
Minimum body weight ≥ 40 kg for all participants.
Exclusion Criteria:
Unresolved toxicities of ≥ Grade 2 from prior therapy
Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy
Patients with central nervous system (CNS) involvement or leptomeningeal disease.
History of allogeneic stem cell transplant or organ transplantation.
Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose of study intervention.
Active infection including Tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
History of arrhythmia which is requires treatment, symptomatic or uncontrol led atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
Uncontrolled intercurrent illness.
Active or prior documented pathologically confirmed autoimmune or inflammatory disorders.
Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
Other invasive malignancy within 2 years prior to screening
Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention
Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Participants 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 participant was enrolled and analyzed for this part of the study.
Recruitment Details
Participants 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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A1
Participants with relapsed or refractory classical Hodgkin Lymphoma (r/r cHL) previously treated with anti-programmed cell death protein-1/programmed cell death-ligand 1 (anti-PD-1/PD-L1) based therapy received 2mg of sabestomig.
FG001
Cohort A2
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 7, 2024
Feb 28, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
China
Germany
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Cohort B2: Dose Expansion
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
The CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants 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).
Up to approximately 2 years 90 days
Part B (Dose Expansion): Number of Participants With AEs
The safety and tolerability of sabestomig in participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
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)
Part A (Dose Escalation): Objective Response Rate (ORR)
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.
The ORR was defined as the percentage of participants 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 participants in the response-evaluable analysis set.
Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
From start of treatment [C1D1 (each cycle was 28 days)] until progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)
Part A (Dose Escalation): Duration of Response (DoR)
The anti-tumor activity of sabestomig in participants 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).
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)
Part A (Dose Escalation): Duration of Complete Response (DoCR)
The anti-tumor activity of sabestomig in participants 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).
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)
Part A (Dose Escalation): Progression-free Survival (PFS)
The anti-tumor activity of sabestomig in participants 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).
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)
Part A (Dose Escalation): Overall Survival (OS)
The anti-tumor activity of sabestomig in participants 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 participant withdraws from treatment or receives another anti-lymphoma therapy.
From start of treatment [C1D1 (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)
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
The presence of ADA for sabestomig in treated participants with r/r cHL was assessed.
On C1D1, C2D1, and until end of study [up to 2 years 5 months (each cycle was 28 days)]
Part A (Dose Escalation): Maximum Observed Concentration (Cmax)
The Cmax of sabestomig in participants with r/r cHL was assessed.
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)]
Part A (Dose Escalation): Area Under the Concentration-time Curve (AUC)
The AUC of sabestomig in participants with r/r cHL was assessed.
From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]
Part A (Dose Escalation): Clearance (CL)
The CL of sabestomig in participants with r/r cHL was assessed.
From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]
Part A (Dose Escalation): Terminal Elimination Half-life (t½λz)
The t½λz of sabestomig in participants with r/r cHL was assessed.
From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]
Part B (Dose Expansion): Duration of Response (DoR)
The DoR of sabestomig in participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
Part B (Dose Expansion): Duration of Complete Response (DoCR)
The DoCR of sabestomig in participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
Part B (Dose Expansion): Progression-free Survival (PFS)
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
Part B (Dose Expansion): Overall Survival (OS)
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
Part B (Dose Expansion): Number of Participants With Positive ADA Against Sabestomig in Serum
The presence of ADA for sabestomig in treated participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
Part B (Dose Expansion): Maximum Observed Concentration (Cmax)
The Cmax of sabestomig in participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
Part B (Dose Expansion): Area Under the Concentration-time Curve (AUC)
The AUC of sabestomig in participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
Part B (Dose Expansion): Terminal Elimination Half-life (t½λz)
The t½λz of sabestomig in participants with r/r cHL was planned to be assessed.
Up to approximately 2 years 90 days
Part B (Dose Expansion): Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Proportion of participants 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 participants 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).
Up to approximately 2 years 90 days
Part B (Dose Expansion): Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE)
Proportion of participants 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 participants would have answered ranged from 17 (assuming that no branching questions were triggered, ie, the participant 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 participant).
Up to approximately 2 years 90 days
Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)
Proportion of participants reporting different levels of overall side-effect bother over time based on the PGI-TT was planned to be evaluated.
For adult participants only, the PGI-TT item was included to assess how a participant perceived the overall burden of treatment-related side effects of cancer treatment over the past 7 days. Participants 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".
Up to approximately 2 years 90 days
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)]
Proportion of participants 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.
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), 2-item global HRQoL (QL2) scale, 5 single items assessing additional symptoms commonly reported by participants with cancer (dyspnea, loss of appetite, insomnia, constipation, and diarrhea), and 1 item on the financial impact of the disease. Participants were planned to answer 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.
Up to approximately 2 years 90 days
From start of treatment [C1D1 (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
FG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
FG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
FG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
FG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
FG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
FG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0045 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0045 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
Type
Comment
Reasons
Ongoing as of DCO (30 Aug 2024)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG00510 subjects
FG00610 subjects
FG0079 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Full analysis set included all participants who received any amount of study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
BG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
BG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
BG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
BG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
BG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
BG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
BG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0021
BG0031
BG0045
BG00512
BG00612
BG00712
BG00845
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG000NA± NAMean was not reported due to concerns with participant's confidentiality. Standard deviation was not calculable for a single participant.
BG001NA± NAMean was not reported due to concerns with participant's confidentiality. Standard deviation was not calculable for a single participant.
BG002
Sex/Gender, Customized
For single participant 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 participant's confidentiality.
Count of Participants
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG0000
BG001
Race/Ethnicity, Customized
For single participant 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 participant's confidentiality.
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0000
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
The safety and tolerability of sabestomig in participants with r/r cHL were assessed.
Safety set included all participants who received any amount of study intervention.
CTCAE = Common Terminology Criteria for Adverse Events (version 5.0)
= As assessed by the investigator.
= AE of special interest derivations were programmed based on sponsor assessment of AE terms.
Posted
Count of Participants
Participants
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)
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Any AE
Title
Measurements
OG0001
OG0011
OG0021
OG003
Other Pre-specified
Part A (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs)
The safety and tolerability of sabestomig in participants 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 participants who received any amount of study intervention.
AE of special interest derivations were programmed based on sponsor assessment of AE terms.
Posted
Count of Participants
Participants
From start of treatment [C1D1 (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Primary
Part A (Dose Escalation): Number of Participants With Dose-limiting Toxicities (DLTs)
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
Safety set included all participants who received any amount of study intervention.
Posted
Count of Participants
Participants
From first dose (C1D1) until 28 days for each participant [within 28 days DLT period]
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Primary
Part B (Dose Expansion): Cohort B1: Objective Response Rate (ORR)
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
ORR was defined as the percentage of participants 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 participants 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).
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG000
Primary
Part B (Dose Expansion): Cohort B2: Complete Response Rate (CRR)
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
The CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants 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).
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG000
Primary
Part B (Dose Expansion): Number of Participants With AEs
The safety and tolerability of sabestomig in participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part A (Dose Escalation): Complete Response Rate (CRR)
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.
The CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set.
Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
Response-evaluable set included all dosed participants who had measurable disease at baseline.
Posted
Number
Percentage of participants
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)
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
Secondary
Part A (Dose Escalation): Objective Response Rate (ORR)
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.
The ORR was defined as the percentage of participants 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 participants in the response-evaluable analysis set.
Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
Response-evaluable set included all dosed participants who had measurable disease at baseline.
Posted
Number
95% Confidence Interval
Percentage of participants
From start of treatment [C1D1 (each cycle was 28 days)] until progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
Secondary
Part A (Dose Escalation): Duration of Response (DoR)
The anti-tumor activity of sabestomig in participants 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 participants who had measurable disease at baseline.
Number of participants analyzed were number of participants with objective response.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Secondary
Part A (Dose Escalation): Duration of Complete Response (DoCR)
The anti-tumor activity of sabestomig in participants 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 participants who had measurable disease at baseline.
Number of participants analyzed were number of participants with complete response.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Secondary
Part A (Dose Escalation): Progression-free Survival (PFS)
The anti-tumor activity of sabestomig in participants 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 participants who received any amount of study intervention.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
Secondary
Part A (Dose Escalation): Overall Survival (OS)
The anti-tumor activity of sabestomig in participants 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 participant withdraws from treatment or receives another anti-lymphoma therapy.
Full analysis set included all participants who received any amount of study intervention.
Posted
Median
95% Confidence Interval
Months
From start of treatment [C1D1 (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)
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Secondary
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
The presence of ADA for sabestomig in treated participants with r/r cHL was assessed.
Immunogenicity analysis set included all participants who received at least 1 dose of study intervention with at least 1 reportable immunogenicity measurement.
Posted
Count of Participants
Participants
On C1D1, C2D1, and until end of study [up to 2 years 5 months (each cycle was 28 days)]
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
Secondary
Part A (Dose Escalation): Maximum Observed Concentration (Cmax)
The Cmax of sabestomig in participants with r/r cHL was assessed.
Pharmacokinetic (PK) set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.
Posted
Median
Full Range
microgram (ug)/milliliter (mL)
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)]
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
Secondary
Part A (Dose Escalation): Area Under the Concentration-time Curve (AUC)
The AUC of sabestomig in participants with r/r cHL was assessed.
PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.
Posted
Median
Full Range
Day*ug/mL
From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
Secondary
Part A (Dose Escalation): Clearance (CL)
The CL of sabestomig in participants with r/r cHL was assessed.
PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.
Posted
Median
Full Range
Liter (L)/Day
From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
Secondary
Part A (Dose Escalation): Terminal Elimination Half-life (t½λz)
The t½λz of sabestomig in participants with r/r cHL was assessed.
PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.
Posted
Median
Full Range
Day
From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]
ID
Title
Description
OG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
OG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
Secondary
Part B (Dose Expansion): Duration of Response (DoR)
The DoR of sabestomig in participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part B (Dose Expansion): Duration of Complete Response (DoCR)
The DoCR of sabestomig in participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part B (Dose Expansion): Progression-free Survival (PFS)
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part B (Dose Expansion): Overall Survival (OS)
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part B (Dose Expansion): Number of Participants With Positive ADA Against Sabestomig in Serum
The presence of ADA for sabestomig in treated participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part B (Dose Expansion): Maximum Observed Concentration (Cmax)
The Cmax of sabestomig in participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part B (Dose Expansion): Area Under the Concentration-time Curve (AUC)
The AUC of sabestomig in participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part B (Dose Expansion): Terminal Elimination Half-life (t½λz)
The t½λz of sabestomig in participants with r/r cHL was planned to be assessed.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG0000
Secondary
Part B (Dose Expansion): Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Proportion of participants 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 participants 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).
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
Secondary
Part B (Dose Expansion): Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE)
Proportion of participants 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 participants would have answered ranged from 17 (assuming that no branching questions were triggered, ie, the participant 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 participant).
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
Secondary
Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)
Proportion of participants reporting different levels of overall side-effect bother over time based on the PGI-TT was planned to be evaluated.
For adult participants only, the PGI-TT item was included to assess how a participant perceived the overall burden of treatment-related side effects of cancer treatment over the past 7 days. Participants 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".
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Counts
Participants
OG000
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)]
Proportion of participants 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.
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), 2-item global HRQoL (QL2) scale, 5 single items assessing additional symptoms commonly reported by participants with cancer (dyspnea, loss of appetite, insomnia, constipation, and diarrhea), and 1 item on the financial impact of the disease. Participants were planned to answer 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.
Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Posted
Up to approximately 2 years 90 days
ID
Title
Description
OG000
Part B
Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.
Units
Time Frame
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)
Description
Safety set included all participants who received any amount of study intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
0
1
0
1
1
1
EG001
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
0
1
0
1
1
1
EG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
0
1
0
1
1
1
EG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
1
1
0
1
1
1
EG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
1
5
3
5
4
5
EG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
1
12
3
12
12
12
EG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
1
12
4
12
10
12
EG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
1
12
2
12
12
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Herpes zoster
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected12 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected12 at risk
Ophthalmic herpes zoster
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sepsis
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Exertional rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected5 at risk
EG0052 events2 affected12 at risk
EG0060 events0 affected12 at risk
EG0075 events5 affected12 at risk
Cystitis
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Device related infection
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Influenza
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Otitis externa
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Skin infection
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Tracheitis
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Acute graft versus host disease in skin
Immune system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Steroid diabetes
Metabolism and nutrition disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Intention tremor
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Secondary cerebellar degeneration
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Tremor
Nervous system disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Retinopathy
Eye disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vision blurred
Eye disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypertension
Vascular disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Lower respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Asthenia
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Chills
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Device related thrombosis
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Fatigue
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pain
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Peripheral swelling
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Amylase increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Eosinophil count increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Lipase increased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Weight decreased
Investigations
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (v27.0)
Non-systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
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.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca.
Mean was not reported due to concerns with participant's confidentiality. Standard deviation was not calculable for a single participant.
BG003NA± NAMean was not reported due to concerns with participant's confidentiality. Standard deviation was not calculable for a single participant.
BG00445.8± 17.6
BG00544.4± 16.0
BG00638.6± 14.5
BG00752.1± 21.2
BG00844.0± 17.4
0
BG0020
BG0030
BG0043
BG0053
BG0062
BG0076
BG00814
Male
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0059
BG00610
BG0076
BG00827
All
Title
Measurements
BG0001
BG0011
BG0021
BG0031
BG0040
BG0050
BG0060
BG0070
BG0084
0
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Not Hispanic or Latino
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0043
BG00512
BG00610
BG00710
BG00835
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0050
BG0061
BG0072
BG0085
Other
Title
Measurements
BG0001
BG0011
BG0021
BG0031
BG0040
BG0050
BG0061
BG0070
BG0085
1
OG0045
OG00512
OG00612
OG00712
1
OG0044
OG00512
OG00610
OG00712
Any AE possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0043
OG00510
OG0068
OG0076
Any AE of CTCAE grade 3 or higher
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0054
OG0062
OG0072
Any AE of CTCAE grade 3 or higher, possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
OG0061
OG0071
Any AE with outcome = death
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
Any AE with outcome = death, possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Any SAE (including events with outcome = death)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0043
OG0052
OG0062
OG0070
Any SAE (including events with outcome = death), possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0052
OG0060
OG0070
Any SAE leading to discontinuation of Sabestomig
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
Any SAE leading to discontinuation of Sabestomig, possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Any AE leading to discontinuation of Sabestomig
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
OG0071
Any AE leading to discontinuation of Sabestomig, possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0071
Any AE leading to cycle delay
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
OG0064
OG0073
Any AE leading to cycle delay, possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
OG0061
OG0070
Any AE of special interest [b]
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0042
OG0058
OG0067
OG0075
Any AE of special interest [b] also considered as an immune-mediated AE [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0053
OG0062
OG0072
Any AE of special interest [b], possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0042
OG0056
OG0064
OG0072
Any AE of special interest [b] also an immune-mediated AE, possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0053
OG0062
OG0072
Any immune-mediated AE [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0053
OG0062
OG0073
Any immune-mediated AE, possibly related to Sabestomig [a]
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0053
OG0062
OG0073
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0045
OG00512
OG00612
OG00712
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0042
OG0058
OG0067
OG0075
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
OG002
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0045
OG00511
OG00612
OG00712
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
0
0
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0045
OG00512
OG00612
OG00712
Title
Denominators
Categories
Title
Measurements
OG000NAHere, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in Statistical analysis plan (SAP).
OG001NAHere, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG002NAHere, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG003NAHere, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG0040
OG00533.3
OG0060
OG0070
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0045
OG00512
OG00612
OG00712
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG001NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG002NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG003NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG0040.0(NA to NA)Here, 'NA' indicated that the upper and lower limit of confidence interval did not cross the 50% probability of ORR.
OG00550.0(21.1 to 78.9)
OG00625.0(5.5 to 57.2)
OG00716.7(2.1 to 48.4)
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0040
OG0056
OG0063
OG0072
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG001NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG002NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG003NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG005NA(2.7 to NA)Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of DoR.
OG0067.7(7.1 to NA)Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of DoR.
OG0076.3(NA to NA)Here, 'NA' indicated that the upper and lower limit of confidence interval did not cross the 50% probability of DoR.
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0054
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG005NA(NA to NA)Here, 'NA' indicated that data (DOCR) was not calculable due to low number of responders with CR events, as pre-specified in SAP.
OG003
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0045
OG00512
OG00612
OG00712
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG001NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG002NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG003NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG0041.9(1.4 to NA)Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of PFS.
OG0054.8(2.4 to 11.9)
OG0065.7(1.8 to NA)Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of PFS.
OG0072.1(1.6 to 8.1)
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0045
OG00512
OG00612
OG00712
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG001NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG002NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG003NA(NA to NA)Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
OG004NA(1.4 to NA)Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of OS.
OG005NA(NA to NA)Here, 'NA' indicated that the median and confidence interval did not cross the 50% probability of OS.
OG006NA(NA to NA)Here, 'NA' indicated that the median and confidence interval did not cross the 50% probability of OS.
OG007NA(8.4 to NA)Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of OS.
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0045
OG00512
OG00612
OG00712
Title
Denominators
Categories
ADA prevalence
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0043
OG0054
OG0064
OG0072
Treatment-induced ADA positive
Title
Measurements
OG0001
OG0010
OG0020
OG003
Treatment-boosted ADA
Title
Measurements
OG0001
OG0010
OG0020
OG003
ADA incidence
Title
Measurements
OG0001
OG0010
OG0020
OG003
ADA positive at baseline and at least one post-baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
ADA positive at baseline and not positive at post-baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
ADA transient positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
ADA persistently positive
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0045
OG00512
OG00611
OG00711
Title
Denominators
Categories
Title
Measurements
OG000NA(0.14 to 0.14)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG001NA(1.41 to 1.41)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG002NA(5.80 to 5.80)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG003NA(15.40 to 15.40)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG00452.49(39.60 to 82.90)
OG005256.00(172.00 to 430.00)
OG006516.00(364.00 to 1480.00)
OG007695.10(323.00 to 1400.00)
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0000
OG0011
OG0021
OG0031
OG0045
OG00511
OG00611
OG00711
Title
Denominators
Categories
Title
Measurements
OG001NA(4.24 to 4.24)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG002NA(28.50 to 28.50)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG003NA(88.80 to 88.80)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG004273.00(110.00 to 518.00)
OG0052256.00(1710.00 to 4780.00)
OG0064687.00(2740.00 to 8370.00)
OG0076883.00(2560.00 to 8120.00)
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0000
OG0011
OG0021
OG0031
OG0044
OG00511
OG0069
OG00711
Title
Denominators
Categories
Title
Measurements
OG001NA(1.3200 to 1.3200)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG002NA(0.7210 to 0.7210)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG003NA(0.8160 to 0.8160)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG0040.4925(0.2910 to 1.9800)
OG0050.2321(0.1030 to 0.4200)
OG0060.2211(0.1010 to 0.3180)
OG0070.2149(0.1280 to 0.7020)
OG004
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
OG005
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
OG006
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
OG007
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
Units
Counts
Participants
OG0000
OG0011
OG0021
OG0031
OG0044
OG00511
OG0069
OG00711
Title
Denominators
Categories
Title
Measurements
OG001NA(2.880 to 2.880)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG002NA(8.980 to 8.980)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
OG003NA(4.730 to 4.730)Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.