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.

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).

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.

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.