RecruitingPhase 1Phase 2NCT07155226

Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression

A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression


Sponsor

AstraZeneca

Enrollment

84 participants

Start Date

Jan 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called AZD3632 — alone or combined with other cancer medicines — for people with advanced blood cancers, including certain types of leukemia and a bone marrow condition called myelodysplastic syndrome (MDS). These cancers have specific genetic changes that cause abnormal growth signals in the cells. **You may be eligible if...** - You have been diagnosed with acute leukemia or MDS with specific genetic mutations (KMT2A rearrangement, NPM1 mutation, or similar HOX pathway changes) - Your cancer came back or stopped responding to standard treatments like chemotherapy or hypomethylating agent therapy - Your white blood cell count is below 25,000 - You are physically able to carry out basic daily activities (low-to-moderate performance status) - You have at least 8 weeks life expectancy **You may NOT be eligible if...** - You have Burkitt lymphoma, Burkitt leukemia, or Acute Promyelocytic Leukemia (APL) - Leukemia has spread to your brain or testicles - You still have significant side effects from a previous cancer treatment - Your potassium or magnesium levels are abnormal 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

DRUGAZD3632

AZD3632 will be administered orally.

DRUGPosaconazole

Posaconazole will be administered orally.


Locations(30)

Research Site

Decatur, Illinois, United States

Research Site

New York, New York, United States

Research Site

Chapel Hill, North Carolina, United States

Research Site

Durham, North Carolina, United States

Research Site

Portland, Oregon, United States

Research Site

Houston, Texas, United States

Research Site

Fitzroy, Australia

Research Site

Perth, Australia

Research Site

Toronto, Ontario, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Copenhagen, Denmark

Research Site

Dresden, Germany

Research Site

Frankfurt A. Main, Germany

Research Site

Halle, Germany

Research Site

Heidelberg, Germany

Research Site

München, Germany

Research Site

Ulm, Germany

Research Site

Bologna, Italy

Research Site

Ravenna, Italy

Research Site

Bunkyō City, Japan

Research Site

Kashiwa, Japan

Research Site

Okayama, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Edinburgh, United Kingdom

Research Site

London, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Newcastle, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07155226


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