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

• Status: Not yet recruiting
• Trial end date: 2025-08-25
• Target enrollment: 0
• Participant gender: All

Summary

The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Parexel

Criteria

Inclusion Criteria:

• Must be ≥ 18 years of age at the time of obtaining informed consent

• Eastern Cooperative Oncology Group performance status of 0 or 1 at screening

• Must have at least one PET-avid measurable lesion according to Modified Lugano Criteria

• Confirmed histological diagnosis of active relapse/refractory cHL

• Must have failed at least 2 prior lines of systemic therapy.

• No previous treatment with anti-TIM-3.

• Adequate organ and bone marrow function measured within 7 days prior to first dose

• 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

Exclusion Criteria:

• Unresolved toxicities of ≥ Grade 2 from prior therapy

• Any prior ≥ Grade 3 imAE while receiving immunotherapy

• Patients with CNS involvement or leptomeningeal disease.

• History of organ transplantation (e.g., stem cell or solid organ transplant).

• Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose of study intervention.

• Active infection including TB, 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 uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia

• Uncontrolled intercurrent illness.

• Active or prior documented 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.