Actively Recruiting

Phase 1
Phase 2
Age: 16Years +
All Genders
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

Led by AstraZeneca · Updated on 2026-04-24

84

Participants Needed

30

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adequate organ function
  • Use of contraception consistent with local regulations
  • Diagnosis of advanced haematologic malignancy with specific genetic alterations linked to HOX overexpression
  • Measurable disease that is relapsed or refractory to standard therapies without available approved options
  • For acute leukemia: prior treatment including at least 2 cycles of intensive chemotherapy or hypomethylating agents
  • For myelodysplastic syndromes (MDS): 5% or more blasts in bone marrow or persistent peripheral blasts after at least 2 cycles of hypomethylating agents, or ineligible for such treatment with no other standard options
  • White blood cell count below 25,000/µL; cytoreduction allowed per protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
  • Life expectancy of at least 8 weeks
Not Eligible

You will not qualify if you...

  • Diagnosis of Burkitt lymphoma/leukemia or acute promyelocytic leukemia
  • Active testicular or central nervous system involvement by leukemia beyond CNS1 or radiographic evidence
  • Unresolved treatment-related toxicities grade 2 or higher from prior therapy
  • Abnormal potassium or magnesium levels before first dose of study drug
  • Receipt of non-CNS radiation therapy within 2 weeks or CNS radiation within 8 weeks before first dose (Module 1)
  • Prior treatment with investigational or non-investigational anticancer agents including other menin inhibitors (Module 1 backfill participants)
  • Diagnosis of diabetes mellitus (type I or II) for nested food effect participants (Module 1)
  • Receipt of any non-investigational anticancer agents or radiation therapy (Module 2)
  • Contraindication to posaconazole treatment per local prescribing information (Module 2)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Trial Site Locations

Total: 30 locations

1

Research Site

Decatur, Illinois, United States, 62526

Actively Recruiting

2

Research Site

New York, New York, United States, 10065

Not Yet Recruiting

3

Research Site

Chapel Hill, North Carolina, United States, 27599

Not Yet Recruiting

4

Research Site

Durham, North Carolina, United States, 27705

Actively Recruiting

5

Research Site

Portland, Oregon, United States, 97239

Not Yet Recruiting

6

Research Site

Houston, Texas, United States, 77030

Actively Recruiting

7

Research Site

Fitzroy, Australia, 3065

Suspended

8

Research Site

Perth, Australia, WA 6000

Suspended

9

Research Site

Toronto, Ontario, Canada, M5G 2M9

Suspended

10

Research Site

Montreal, Quebec, Canada, H3T 1E2

Suspended

11

Research Site

Copenhagen, Denmark, 2100

Actively Recruiting

12

Research Site

Dresden, Germany, 01307

Actively Recruiting

13

Research Site

Frankfurt A. Main, Germany, 60590

Actively Recruiting

14

Research Site

Halle, Germany, 06097

Actively Recruiting

15

Research Site

Heidelberg, Germany, 69120

Actively Recruiting

16

Research Site

München, Germany, 81377

Actively Recruiting

17

Research Site

Ulm, Germany, 89081

Actively Recruiting

18

Research Site

Bologna, Italy, 40138

Actively Recruiting

19

Research Site

Ravenna, Italy, 48121

Actively Recruiting

20

Research Site

Bunkyō City, Japan, 113-8677

Actively Recruiting

21

Research Site

Kashiwa, Japan, 277-8577

Not Yet Recruiting

22

Research Site

Okayama, Japan, 700-8558

Actively Recruiting

23

Research Site

Seoul, South Korea, 06351

Actively Recruiting

24

Research Site

Seoul, South Korea, 06591

Actively Recruiting

25

Research Site

Seoul, South Korea, 110-744

Actively Recruiting

26

Research Site

Edinburgh, United Kingdom, EH4 2XU

Actively Recruiting

27

Research Site

London, United Kingdom, EC1A 7BE

Not Yet Recruiting

28

Research Site

London, United Kingdom, SE5 9RS

Actively Recruiting

29

Research Site

Manchester, United Kingdom, M20 4BX

Actively Recruiting

30

Research Site

Newcastle, United Kingdom, NE7 7DN

Suspended

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

7

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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 | DecenTrialz