Non Hodgkin Lymphoma Clinical Trial

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

Summary

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 cHL).

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Full Description

This is a Phase I/II, open-label multi-center study will have AZD7789 administered via intravenous infusion on Cycle 1 Day 1 to 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.

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Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05216835

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 20 Locations for this study

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Research Site
Duarte California, 91010, United States
Research Site
Miami Florida, 33136, United States
Research Site
Boston Massachusetts, 02215, United States
Research Site
Rochester Minnesota, 55905, United States
Research Site
New York New York, 10065, United States
Research Site
Houston Texas, 77030, United States
Research Site
Vancouver British Columbia, V5Z 4, Canada
Research Site
Toronto Ontario, M5G 1, Canada
Research Site
Montreal Quebec, H3T 1, Canada
Research Site
København Ø , 2100, Denmark
Research Site
Odense , 5000, Denmark
Research Site
Lille Cedex , 59037, France
Research Site
Paris , 75010, France
Research Site
Köln , 50924, Germany
Research Site
Bologna , 40138, Italy
Research Site
Napoli , 80131, Italy
Research Site
Barcelona , 08035, Spain
Research Site
Valencia , 46010, Spain
Research Site
Manchester , M20 4, United Kingdom
Research Site
Oxford , 0X3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05216835

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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