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Study of AZD3632 for Advanced Blood Cancers

This study is testing a new oral drug called AZD3632, alone or with another oral drug called Posaconazole, for people with advanced blood cancers like Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, or higher-risk Myelodysplastic Syndromes. Researchers want to learn about the safety, how well the body handles the drug (tolerability), and how effective it is. They are particularly interested in patients whose cancer has specific genetic changes (KMT2Ar, NPM1m, or other genotypes linked to HOX overexpression). The study will look at side effects and how many patients experience them, as well as how often treatment needs to be adjusted or stopped due to side effects. This study is open to people aged 16 and older.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 84 participants and includes different modules to test AZD3632 alone and in combination with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects for up to 30 days after their last dose, which could be for approximately 3 years and 1 month.

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NCT07155226

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

Recruiting
PHASE1Ages 16+InterventionalTreatment
AstraZeneca
~84 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:AZD3632Posaconazole

At a glance

Recruiting sites
21 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Module 1: Number of participants with dose-limiting toxicity (DLT)
Measured over At the end of Cycle 1 (each cycle is 28 days)
+2 more outcomes measured

Conditions

Acute Lymphoblastic Leukaemia
Acute Myeloid Leukaemia
Higher-risk Myelodysplastic Syndromes

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaHematologic NeoplasmMyelodysplastic SyndromeHOXA Gene FamilyKMT2A GeneNPM1 Gene

Where it's being run

30 sites across 14 states
Germany6
United Kingdom5
Japan3
South Korea3
North Carolina2
Australia2
Italy2
Illinois1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

Adequate organ function.
Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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.

Exclusion

Participants with Burkitt lymphoma/leukaemia or Acute Promyelocytic Leukaemia.
Active testicular or active central nervous system (CNS) (\> CNS1 or radiographic) involvement by leukaemia.
Unresolved treatment-related toxicities Grade ≥ 2 from prior therapy.
Abnormal levels of potassium or magnesium prior to first dose of AZD3632.
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.
Participants for whom treatment with posaconazole is contraindicated per the local prescribing information.

What this trial measures

  • Module 1: Number of participants with dose-limiting toxicity (DLT)At the end of Cycle 1 (each cycle is 28 days)

    Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.

  • Module 1 and Module 2: Number of participants with dose modification, delay and discontinuations due to adverse events (AEs)Up to 3 years 1 month

    Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.

  • Module 1 and Module 2: Number of participants with treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs) and serious adverse vents (SAEs)Up to 30 days after last dose (approximately 3 years 1 month)

    Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed. Adverse events will be defined as treatment-emergent if they have an onset or worsen (by investigator report of a change in intensity) during the study treatment or the safety follow-up period but prior to any subsequent cancer therapy.