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 AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r
- ≥ 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 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
- Minimum body weight ≥ 40 kg for all participants.
- Unresolved toxicities of ≥ Grade 2 from prior therapy
- Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor 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 pathologically confirmed autoimmune or inflammatory
- 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.