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MOMENTUMAZD3632 for Advanced Hematologic Malignancies with HOX Overexpression

Study Aim

This study aims to evaluate the safety and tolerability of AZD3632 in adults with advanced blood cancers that have HOX gene overexpression.

What is being tested

AZD3632

+ Posaconazole

Drug

Who is being recruted

Bone Marrow Diseases+12

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 16 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: December 11, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: January 12, 2026

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new medication called AZD3632 for individuals with advanced blood cancers like relapsed or resistant acute leukemia or myelodysplastic syndromes (MDS), specifically those with certain genetic markers linked to HOX overexpression. The aim is to assess the safety and effectiveness of this drug, either on its own or combined with other cancer treatments. This research is essential as it seeks to discover better treatment options for patients with these challenging conditions, where current therapies may not work effectively. Participants in the study will receive AZD3632, with some receiving just this medication, while others will have it combined with another drug, posaconazole. The study will begin by determining the right dosage of AZD3632 to ensure it is safe and well-tolerated. Researchers will closely monitor participants to measure how the body processes the drug and its effects on the cancer. Through these steps, the study aims to gather vital information on the drug's safety profile and its potential benefits in treating these specific blood cancers.

Official TitleA 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

NCT07155226

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: December 11, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMyelodysplastic SyndromesNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Criteria

5 inclusion criteria required to participate

Advanced haematologic malignancy - a) for dose escalation - diagnosis of acute leukemia or myelodysplastic neoplasia (MDS) and harbouring one of the genetic alterations per local testing associated with upregulation of HOX; b) for Backfill - diagnosis of harbouring a KMT2Ar or NPM1m per local testing.

Participants must have measurable disease that is relapsed/refractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory acute leukaemia after standard of care therapy including but not limited to 2 cycles of intensive chemotherapy, hypomethylating agent (HMA) monotherapy, or HMA combinations such as HMA/venetoclax.; b) Relapsed and primary refractory MDS is defined by ≥ 5% blasts in the bone marrow and/or persistence of peripheral blasts after treatment with at least 2 cycles of HMA. Participants ineligible for the treatment with an HMA and without any other standard of care (SoC) options are allowed to enrol; c) White blood cell count below 25,000/μL. Participants may receive cytoreduction per protocol-specified criteria; d) Performance status: Eastern Cooperative Operative Group (ECOG) ≤ 2; e) Life expectancy: ≥ 8 weeks.

Participants must have measurable disease that is relapsed/refractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory acute leukaemia after standard of care therapy including but not limited to 2 cycles of intensive chemotherapy, HMA monotherapy, or HMA combinations such as HMA/venetoclax.; b) Relapsed and primary refractory MDS is defined by ≥ 5% blasts in the bone marrow and/or persistence of peripheral blasts after treatment with at least 2 cycles of HMA. Participants ineligible for the treatment with an HMA and without any other SoC options are allowed to enrol; c) White blood cell count below 25,000/μL. Participants may receive cytoreduction per protocol-specified criteria; d) Performance status: ECOG ≤ 2; e) Life expectancy: ≥ 8 weeks.

Adequate organ function.

Show More Criteria

9 exclusion criteria prevent from participating

Receipt of non-CNS radiation therapy within 2 weeks and of CNS radiation within 8 weeks of the first scheduled dose.

Receipt of any investigational or non-investigational anticancer agents, including non-biologic agents, biologic agents and/or prior treatment other menin inhibitors (backfill participants only).

For nested food effect participants - diagnosis of diabetes mellitus (Type I or Type II).

Receipt of any non-investigational anticancer agents, including non-biologic agents and/or biologic agents or receipt of non-CNS or CNS radiation therapy.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

7 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive AZD3632 (dose 1) through the treatment period.

Group II

Experimental

Participants will receive AZD3632 (dose 2) through the treatment period.

Group III

Experimental

Participants will receive AZD3632 (dose 3) through the treatment period.

Group IV

Experimental

Participants will receive AZD3632 (dose 4) through the treatment period.

Group 5

Experimental

Participants will receive AZD3632 (dose 5) through the treatment period.

Group 6

Experimental

Participants will receive AZD3632 (dose 6) through the treatment period.

Group 7

Experimental

Participants will receive AZD3632 alone, then will receive AZD3632 in combination with posaconazole through treatment period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 29 locations

Suspended

Research Site

Decatur, United StatesSee the location

Suspended

Research Site

New York, United States

Suspended

Research Site

Durham, United States

Suspended

Research Site

Portland, United States

Recruiting soon29 Study Centers