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Clinical Trials in the USA / NCT07155226
Recruiting Phase 1/2

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

NCT07155226 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 1/2
Started
2026-01-09
Last updated
2026-07-20

Condition(s) studied

Acute Lymphoblastic LeukaemiaAcute Myeloid LeukaemiaHigher-risk Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

AZD3632Posaconazole

AZD3632: AZD3632 will be administered orally.

Posaconazole: Posaconazole will be administered orally.

Study summary

The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.

Eligibility

Sex
ALL
Min age
16 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: Core 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. Key Exclusion Criteria: Core 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.

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Research Site Decatur Illinois Recruiting
Research Site New York New York Not Yet Recruiting
Research Site Chapel Hill North Carolina Not Yet Recruiting
Research Site Durham North Carolina Recruiting
Research Site Portland Oregon Suspended
Research Site Houston Texas Recruiting
Research Site Fitzroy Australia Suspended
Research Site Perth Australia Suspended
Research Site Toronto Ontario Suspended
Research Site Montreal Quebec Suspended
Research Site Copenhagen Denmark Recruiting
Research Site Dresden Germany Recruiting
Research Site Frankfurt A. Main Germany Recruiting
Research Site Halle Germany Recruiting
Research Site Heidelberg Germany Recruiting
Research Site München Germany Recruiting
Research Site Ulm Germany Recruiting
Research Site Bologna Italy Recruiting
Research Site Ravenna Italy Recruiting
Research Site Bunkyō City Japan Recruiting
Research Site Kashiwa Japan Not Yet Recruiting
Research Site Okayama Japan Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Edinburgh United Kingdom Recruiting
Research Site London United Kingdom Recruiting
Research Site London United Kingdom Recruiting
Research Site Manchester United Kingdom Recruiting
Research Site Newcastle United Kingdom Suspended
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07155226 on ClinicalTrials.gov ↗ ← All trials in the USA