Clinical trial · Interventional
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Classical Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sabestomig (AZD7789) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A: Dose Escalation
- description
- Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig to determine the recommended phase 2 dose (RP2D).
- interventionNames
- Drug: Sabestomig (AZD7789)
- type
- EXPERIMENTAL
- label
- Cohort B1: Dose Expansion
- description
- Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig once the RP2D has been determined.
- interventionNames
- Drug: Sabestomig (AZD7789)
- type
- EXPERIMENTAL
- label
- Cohort B2: Dose Expansion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 101 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available