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
NCT ID: NCT07155226
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2026-01-09
2029-02-15
Brief Summary
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Detailed Description
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This study includes multiple modules (module 1 and module 2) each investigating AZD3632 in a specific population and/or in combination with other anticancer agents.
Module 1 is a dose escalation of AZD3632 monotherapy. Module 2 will investigate the safety, PK, and tolerability when co-administered with posaconazole.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Module 1: AZD3632 dose 1
Participants will receive AZD3632 (dose 1) through the treatment period.
AZD3632
AZD3632 will be administered orally.
Module 1: AZD3632 dose 2
Participants will receive AZD3632 (dose 2) through the treatment period.
AZD3632
AZD3632 will be administered orally.
Module 1: AZD3632 dose 3
Participants will receive AZD3632 (dose 3) through the treatment period.
AZD3632
AZD3632 will be administered orally.
Module 1: AZD3632 dose 4
Participants will receive AZD3632 (dose 4) through the treatment period.
AZD3632
AZD3632 will be administered orally.
Module 1: AZD3632 dose 5
Participants will receive AZD3632 (dose 5) through the treatment period.
AZD3632
AZD3632 will be administered orally.
Module 1: AZD3632 dose 6
Participants will receive AZD3632 (dose 6) through the treatment period.
AZD3632
AZD3632 will be administered orally.
Module 2: AZD3632 + posaconazole
Participants will receive AZD3632 alone, then will receive AZD3632 in combination with posaconazole through treatment period.
AZD3632
AZD3632 will be administered orally.
Posaconazole
Posaconazole will be administered orally.
Interventions
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AZD3632
AZD3632 will be administered orally.
Posaconazole
Posaconazole will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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.
Module 1:
* 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.
Module 2:
* 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 Criteria
* 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.
Module 1:
* 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).
Module 2:
* 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.
16 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Newcastle, , United Kingdom
Research Site
Decatur, Illinois, United States
Research Site
New York, New York, 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
Countries
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Central Contacts
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Other Identifiers
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2025-521299-76-00
Identifier Type: OTHER
Identifier Source: secondary_id
D8620C00001
Identifier Type: -
Identifier Source: org_study_id
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