RecruitingPhase 1Phase 2NCT06137144

AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.

A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, and Efficacy of AZD3470, a PRMT5 Inhibitor, as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies

Sponsor

AstraZeneca

Enrollment

161 participants

Start Date

Jan 23, 2024

Study Type

INTERVENTIONAL

Conditions

Hodgkin Lymphoma Non-Hodgkin Lymphoma Lymphoma Peripheral T-cell Lymphoma (PTCL)PTCL-NOS ALCL AITL

Summary

This study is designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called AZD3470, alone or combined with other cancer drugs, for people with relapsed or refractory classical Hodgkin lymphoma (cHL) — a type of blood cancer that has stopped responding to prior treatments. The drug targets a specific protein involved in cancer cell survival. **You may be eligible if...** - You are 18 or older (dose escalation phase) or at least 15 years old (expansion phase) - You have a confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma - Your overall health is good (ECOG performance status 0 or 1) - Your organs (bone marrow, liver, kidneys) are functioning adequately - You are willing to provide a tumor tissue sample for testing - You are willing to use contraception if applicable **You may NOT be eligible if...** - You have poor organ function - You do not meet the tissue sample requirements - You do not meet the performance status requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD3470

AZD3470 is a novel, potent and selective, second-generation, Methylthioadenosine (MTA)-selective, small molecule inhibitor of PRMT5.

DRUGPembrolizumab

Pembrolizumab (CAS nr: 1374853-91-4 )

Locations(33)

Research Site

Duarte, California, United States

Research Site

Miami, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Houston, Texas, United States

Research Site

Adelaide, Australia

Research Site

Fitzroy, Australia

Research Site

Nedlands, Australia

Research Site

South Brisbane, Australia

Research Site

Waratah, Australia

Research Site

Beijing, China

Research Site

Guangzhou, China

Research Site

Shanghai, China

Research Site

Créteil, France

Research Site

Lille, France

Research Site

Pierre-Bénite, France

Research Site

Villejuif, France

Research Site

Berlin, Germany

Research Site

Cologne, Germany

Research Site

Erlangen, Germany

Research Site

Würzburg, Germany

Research Site

Alessandria, Italy

Research Site

Bologna, Italy

Research Site

Milan, Italy

Research Site

Kōtoku, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

L'Hospitalet de Llobregat, Spain

Research Site

Madrid, Spain

Research Site

Manchester, United Kingdom

Research Site

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06137144

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