Actively Recruiting
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
Eligibility Criteria
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
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
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
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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