MOMENTUM
Research type
Research Study
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
IRAS ID
1012626
Contact name
David Alanby Johnson
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
The trial drug AZD3632 is designed to help reduce HOX gene overexpression by blocking the menin protein from binding to the KMT2A protein. Researchers believe that this will help treat the participants’ blood cancer and allow immature blood cells to grow into healthy, mature cells. In this trial, researchers want to learn how safe AZD3632 is, how well it works, and how it moves throughout the body in participants at least 18 years old, with acute leukemia or myelodysplastic syndrome with HOX gene overexpression. This trial will include about 126 participants.
AZ is the sponsor of this Phase 1/2, open-label trial. Open-label means the participants, researchers and trial staff will know what each participant is taking. The participants will continue to receive trial treatment unless their cancer gets worse, they have significant medical problems, or they leave the trial for another reason.
This trial will be made up of multiple parts called “modules”. In Module 1, researchers will give different groups of participants increasing doses of AZD3632 to learn which doses are the most safe and effective. In Module 2, researchers will test how AZD3632 interacts with another drug called posaconazole. Posaconazole is normally used to prevent or treat fungal infections, but it also slows activity of a certain protein that's responsible for processing several medications including AZD3632. Researchers want to learn how posaconazole may impact the way AZD3632 moves throughout the body over time.
AZD3632 and posaconazole are both taken by mouth as tablets daily in 28-day cycles.
They will have regular study site visits for blood tests, bone marrow biopsies, imaging scans, and other assessments. The total duration for each participant may be several months or longer if they are benefiting from treatment.
It’s not certain if taking part will help a participant’s condition, but information from this study may help better treat patients with acute leukaemia or MDS in the future.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0196
Date of REC Opinion
20 Oct 2025
REC opinion
Further Information Favourable Opinion