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

Protocol # :
Relapsed or Refractory Classical Hodgkin Lymphoma
Disease Sites
Hodgkin's Lymphoma
Principal Investigator
Armand, Philippe
Site Research Nurses
Brennan, Lisa
Kilcommons, Marykate
Normilus, Samantha
Patterson, Victoria

Trial Description

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

Eligibility Requirements

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 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.

Exclusion Criteria:

- 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.