Status:
COMPLETED
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Relapsed or Refractory Classical Hodgkin Lymphoma
Eligibility:
All Genders
16-101 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05216835
Start Date
March 18 2022
End Date
September 4 2025
Last Update
October 2 2025
Active Locations (14)
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1
Research Site
Duarte, California, United States, 91010
2
Research Site
Miami, Florida, United States, 33136
3
Research Site
Rochester, Minnesota, United States, 55905
4
Research Site
New York, New York, United States, 10065