Relapsed or Refractory Classical Hodgkin LymphomaPhase 1NCT05216835
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
A Phase 1 study testing Sabestomig (AZD7789) in people with Relapsed or Refractory Classical Hodgkin Lymphoma, run by AstraZeneca at 14 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 101 years
- Conditions the study is for
- Relapsed or Refractory Classical Hodgkin Lymphoma
- What is being tested?
- Sabestomig (AZD7789)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 18 Mar 2022to 4 Sep 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 101 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
United States5 sites
Research Site
Duarte, California, 91010
Research Site
Houston, Texas, 77030
Research Site
Miami, Florida, 33136
Research Site
New York, New York, 10065
Research Site
Rochester, Minnesota, 55905
Canada2 sites
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Toronto, Ontario, M5G 1X6
United Kingdom2 sites
Research Site
Manchester, M20 4BX
Research Site
Oxford, 0X3 7LJ
About this study
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.
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).
Read the 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.
- Being tested
- Sabestomig (AZD7789)
- 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
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabestomig (AZD7789)Drug
Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Drug: Sabestomig (AZD7789) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: Up to approximately 2 years 90 days
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).
Measured: 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.
Measured: Up to approximately 2 years 90 days
Secondary outcomes (23)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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".
Measured: 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.
Measured: Up to approximately 2 years 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start18 Mar 2022
- Primary completion30 Aug 2024
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed or Refractory Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216835
- Sponsor's protocol ID
- D9571C00001
- Other IDs
- 2021-003569-36
- Status last verified
- Sep 2025
- First submitted
- 19 Jan 2022
- Last updated
- 2 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05216835
- Acronym / sponsor ID
- D9571C00001
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Posted 2 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Dose Escalation | Experimental | Drug: Sabestomig (AZD7789)Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig to determine the recommended phase 2 dose (RP2D). |
| Cohort B1: Dose Expansion | Experimental | Drug: Sabestomig (AZD7789)Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig once the RP2D has been determined. |
| Cohort B2: Dose Expansion | Experimental | Drug: Sabestomig (AZD7789)Patients with anti-PD-1/PD-L1 naïve r/r cHL will receive sabestomig once the RP2D has been determined. |
Who may qualify
- Ages
- 16 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sabestomig (AZD7789)Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion. | Drug | Cohort A: Dose Escalation, Cohort B1: Dose Expansion, Cohort B2: Dose Expansion |
Primary outcome
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
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)
The safety and tolerability of sabestomig in participants with r/r cHL were assessed.
Part A (Dose Escalation): Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: From first dose (C1D1) until 28 days for each participant [within 28 days DLT period]
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
Part B (Dose Expansion): Cohort B1: Objective Response Rate (ORR)
Time frame: Up to approximately 2 years 90 days
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 (Dose Expansion): Cohort B2: Complete Response Rate (CRR)
Time frame: Up to approximately 2 years 90 days
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 (Dose Expansion): Number of Participants With AEs
Time frame: Up to approximately 2 years 90 days
The safety and tolerability of sabestomig in participants with r/r cHL was planned to be assessed.
23 secondary outcomes
Part A (Dose Escalation): Complete Response Rate (CRR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to approximately 2 years 90 days
Part B (Dose Expansion): Duration of Complete Response (DoCR)
Time frame: Up to approximately 2 years 90 days
Part B (Dose Expansion): Progression-free Survival (PFS)
Time frame: Up to approximately 2 years 90 days
Part B (Dose Expansion): Overall Survival (OS)
Time frame: Up to approximately 2 years 90 days
Part B (Dose Expansion): Number of Participants With Positive ADA Against Sabestomig in Serum
Time frame: Up to approximately 2 years 90 days
Part B (Dose Expansion): Maximum Observed Concentration (Cmax)
Time frame: Up to approximately 2 years 90 days
Part B (Dose Expansion): Area Under the Concentration-time Curve (AUC)
Time frame: Up to approximately 2 years 90 days
Part B (Dose Expansion): Terminal Elimination Half-life (t½λz)
Time frame: 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)
Time frame: 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)
Time frame: Up to approximately 2 years 90 days
Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)
Time frame: 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)]
Time frame: Up to approximately 2 years 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSR synopsisLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Relapsed or Refractory Classical Hodgkin Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
RecruitingPhase 1/2
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma
RecruitingPhase 2
ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
Hodgkin Lymphoma, Adult, Refractory Hodgkin Lymphoma
Active, not recruitingPhase 1
Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas
Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type, Classical Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sabestomig (AZD7789) in people with Relapsed or Refractory Classical Hodgkin Lymphoma, run by AstraZeneca at 14 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Italy, United Kingdom, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs) (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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.