AstraZene- AZD3632 Mono or in Comb with Anticancer Agents in subjects with w/ KMT2Ar, NPM1m, w/ HOX - Clinical Trial

What is the Purpose of this Study?

This study has three parts:

- Screening (up to 21 days): You'll get health checks like heart tests, scans, and blood work.

- Study Drug Period (28-day cycles): You'll be randomly placed in one of two groups:

- One group gets AZD3632 alone.

-The other gets AZD3632 with another medicine called posaconazole. You'll have regular visits for tests and questions.

- After Treatment: You'll have a safety check 30 days after your last dose, then visits every 12 weeks to see how your disease is doing.

What is the Condition Being Studied?

Adults with acute leukemia or myelodysplastic syndromes (MDS)

Who Can Participate in the Study?

Adults with certain blood cancers; like AML, ALL, MPAL, AUL, or MDS—can join this study. Some parts of the study are for people whose cancer has come back, which means there are more than 5% cancer cells in their bone marrow again.

Age Group
Adults

What is Involved?

This study is being done to see if a new medicine called AZD3632 is safe and works well for people with certain blood cancers called acute leukemia or MDS.

Study Details

Full Title
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
Principal Investigator
Harry P. Erba, MD, PhD
Hematologic Oncologist
Protocol Number
IRB: PRO00118800
NCT: NCT07155226
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
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