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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • 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
Where Is This Study? (5 UK sites)
Research Site
Edinburgh EH4 2XU, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Research Site
London SE5 9RS, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Newcastle NE7 7DN, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
