Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Completed · Phase 1

Conditions studied: Relapsed or Refractory Classical Hodgkin Lymphoma

In brief

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).

Key facts

Study ID

NCT05216835

Run by

AstraZeneca

People needed

45

Starts

2022-03-18

Expected to finish

2025-09-04

Last updated by the study team

2025-10-02

Who can join

Age: 16 and older, up to 101. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — New York, New York, United States
• Research Site — Houston, Texas, United States
• Research Site — Toronto, Ontario, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — København Ø, Denmark
• Research Site — Lille, France
• Research Site — Bologna, Italy
• Research Site — Naples, Italy
• Research Site — Valencia, Spain
• Research Site — Manchester, United Kingdom
• Research Site — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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