Recruiting
Phase 1
Phase 2

AZD3632

Sponsor:

AstraZeneca

Code:

NCT07155226

Conditions

Acute Lymphoblastic Leukaemia

Acute Myeloid Leukaemia

Higher-risk Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

AZD3632

Posaconazole

Study Details

Brief 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.

Conditions

Acute Lymphoblastic Leukaemia

Acute Myeloid Leukaemia

Higher-risk Myelodysplastic Syndromes

Study ID

NCT07155226

Start date

Jan 9, 2026

Status verified date

Jul, 2026

Completion date

Feb 15, 2029

Anticipated

Primary completion date

Feb 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1: AZD3632 dose 1

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

experimental: Module 1: AZD3632 dose 2

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

experimental: Module 1: AZD3632 dose 3

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

experimental: Module 1: AZD3632 dose 4

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

experimental: Module 1: AZD3632 dose 5

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

experimental: Module 1: AZD3632 dose 6

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

experimental: Module 2: AZD3632 + posaconazole

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

Interventions

AZD3632

AZD3632 will be administered orally.

Posaconazole

Posaconazole will be administered orally.

Primary outcome measure

  • Module 1: Number of participants with dose-limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
  • Module 1 and Module 2: Number of participants with dose modification, delay and discontinuations due to adverse events (AEs) [ Time Frame: Up to 3 years 1 month ]
  • Module 1 and Module 2: Number of participants with treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs) and serious adverse vents (SAEs) [ Time Frame: Up to 30 days after last dose (approximately 3 years 1 month) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Decatur, Illinois, United States, 62526

Research Site

Recruiting

Durham, North Carolina, United States, 27705

Research Site

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

AstraZeneca

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Myelodysplastic Syndromes
  • Menin inhibitor
  • Anti-leukaemic activity
  • Anti-fungal agent
  • HOX overexpression.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-20.