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

Part of paid clinical trials in Decatur, Illinois.

Sponsor
AstraZeneca
Study ID
NCT07155226
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukaemia
  • Acute Myeloid Leukaemia
  • Higher-risk Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD3632 — DRUG
    AZD3632 will be administered orally.
  • Posaconazole — DRUG
    Posaconazole will be administered orally.

Study Details

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.

Key Dates

Start date
Jan 9, 2026
Status verified
Jun 2026
Primary completion
Feb 15, 2029
Completion
Feb 15, 2029

Study Design

Enrollment
84 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteDecaturIllinois62526-
Research SiteNew YorkNew York10065-
Research SiteChapel HillNorth Carolina27599-
Research SiteDurhamNorth Carolina27705-
Research SitePortlandOregon97239-
Research SiteHoustonTexas77030-

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