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Looking for participantsPhase1/Phase2

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

Sponsor: AstraZeneca

NCT ID: NCT07155226

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD3632 (drug), Posaconazole (drug)
How long the study runs
Study runs about 37 months (dates as stated)
About the drug or intervention
AZD3632 — drug: AZD3632 will be administered orally. · Posaconazole — drug: Posaconazole will be administered orally.
Patient visit burden
Not specified by the sponsor

In plain English

This AstraZeneca study is testing a drug called AZD3632, on its own or with other cancer medicines, in people with advanced blood cancers. These include acute lymphoblastic leukaemia, acute myeloid leukaemia, and higher-risk myelodysplastic syndromes. The cancers must have certain gene changes, such as KMT2A rearrangement or an NPM1 change, or other gene changes linked to high levels of something called HOX.

Who can take part

  • The main organs (such as the liver and kidneys) must be working well enough.
  • Participants or their partners must use contraception, following local rules for people taking part in research studies.
  • The cancer must have come back (relapsed) or not responded (refractory) to standard treatments that are known to work, and there must be no approved treatments left as an option.
  • For acute leukaemia: the disease came back or did not respond after standard care, for example at least 2 cycles of strong chemotherapy, or treatment with a hypomethylating agent (a type of drug) on its own or combined with other drugs such as venetoclax.
  • For myelodysplastic syndromes: at least 5% blast cells (early blood cells) in the bone marrow, or blast cells still in the blood, after at least 2 cycles of a hypomethylating agent. People who cannot have this treatment and have no other standard option may still join.
  • White blood cell count below 25,000 per microlitre. Medicine to lower the count may be given under the study rules.
  • Able to carry out daily activities with little or no help (performance status score of 2 or less on a scale called ECOG).
  • Expected to live at least 8 weeks.
  • For one part of the study: a diagnosis of acute leukaemia or a myelodysplastic condition with one of the gene changes linked to high HOX levels, or a KMT2A rearrangement or NPM1 change for another part.

Who may not be able to

  • Burkitt lymphoma or leukaemia, or acute promyelocytic leukaemia.
  • Leukaemia that is actively affecting the brain or spinal cord (the central nervous system) beyond a certain level, or actively affecting the testicles.
  • Side effects from earlier treatment that are grade 2 or worse and have not settled down.
  • Abnormal levels of potassium or magnesium in the blood before the first dose of AZD3632.
  • Radiotherapy (not to the brain or spinal cord) within 2 weeks, or radiotherapy to the brain or spinal cord within 8 weeks, of the first planned dose (one part of the study).
  • Any other cancer treatment, whether part of research or approved, including biological drugs. People joining one part of the study must not have had other drugs called menin inhibitors.
  • Diabetes (type 1 or type 2), for people taking part in a small extra part of the study looking at food effects.
  • Cannot take a medicine called posaconazole (one part of the study), according to local prescribing information.

What taking part involves

  • • Taking the study drug AZD3632 on its own or together with other anti-cancer medicines.
  • • Regular checks and tests as part of the study to see how the treatment is working and how the body is coping.

Time commitment: Not stated — ask the trial team: how many visits are needed, how long the study lasts, and what taking part day to day involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
16 Years and over
Who
All
Number of participants
84
Started
2026-01-09
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for acute lymphoblastic leukaemia
  • • Phase1/Phase2 - 84 participants
  • • 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

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with acute lymphoblastic leukaemia

Where?

  • • Edinburgh - Research Site
  • • London - Research Site
  • • London - Research Site
  • • Manchester - Research Site
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a first in human (FTiH), open-label, multi-centre study of AZD3632 in participants with relapsed or refractory acute leukaemia or myelodysplastic Syndromes (MDS) with HOX overexpression genotypes. This study includes multiple modules (module 1 and module 2) each investigating AZD3632 in a specific population and/or in combination with other anticancer agents. Module 1 is a dose escalation of AZD3632 monotherapy. Module 2 will investigate the safety, PK, and tolerability when co-administered with posaconazole.

Acute Lymphoblastic LeukaemiaAcute Myeloid LeukaemiaHigher-risk Myelodysplastic Syndromes

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

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  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 2 or better

What the study is looking for

  • ✓Core criteria:
  • ✓healthy organ.
  • ✓Contraceptive use by participants or participant partners should be consistent with local regulations regarding the...
  • ✓Module 1:
  • ✓Module 2:

Who cannot take part

  • ✗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.
See the full criteria
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.

Where Is This Study? (5 UK sites)

Research Site

Edinburgh EH4 2XU, United Kingdom

Recruiting

Research Site

London EC1A 7BE, United Kingdom

Recruiting

Research Site

London SE5 9RS, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Newcastle NE7 7DN, United Kingdom

SUSPENDED

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07