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

This is an interventional treatment trial for Relapsed or Refractory Classical Hodgkin Lymphoma focused on measuring 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 Read More

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.