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New pill takes aim at genetic weakness in tough blood cancers

NCT ID NCT07155226

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This early-phase study is testing an experimental oral drug called AZD3632 in about 84 people with advanced blood cancers (acute leukemias or myelodysplastic syndromes) that have certain genetic changes. The main goals are to check the drug's safety and find the right dose, while also looking for early signs that it might help control the disease. Participants receive the drug alone or with another medication to see how the body processes it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD3632 (an experimental oral drug)
What this could lead to
If it works, this could point toward a new treatment option for people with certain hard-to-treat blood cancers.
What could go wrong
This is an early-phase trial with only 84 participants, so it is too soon to know if the drug is safe or effective. Many experimental cancer drugs fail in early testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloblastic leukemia with maturation acute myeloid leukemia adult acute lymphoblastic leukemia childhood acute lymphoblastic leukemia myelodysplastic syndrome Myelodysplastic Syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukaemia Acute myeloid leukaemia Higher-risk myelodysplastic syndromes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Research Site

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • Research Site

    NOT_YET_RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Research Site

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Research Site

    SUSPENDED

    Portland, Oregon, 97239, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    SUSPENDED

    Fitzroy, 3065, Australia

  • Research Site

    SUSPENDED

    Perth, WA 6000, Australia

  • Research Site

    SUSPENDED

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    SUSPENDED

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    RECRUITING

    Copenhagen, 2100, Denmark

  • Research Site

    RECRUITING

    Dresden, 01307, Germany

  • Research Site

    RECRUITING

    Frankfurt A. Main, 60590, Germany

  • Research Site

    RECRUITING

    Halle, 06097, Germany

  • Research Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Research Site

    RECRUITING

    München, 81377, Germany

  • Research Site

    RECRUITING

    Ulm, 89081, Germany

  • Research Site

    RECRUITING

    Bologna, 40138, Italy

  • Research Site

    RECRUITING

    Ravenna, 48121, Italy

  • Research Site

    RECRUITING

    Bunkyō City, 113-8677, Japan

  • Research Site

    NOT_YET_RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    RECRUITING

    Okayama, 700-8558, Japan

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 06591, South Korea

  • Research Site

    RECRUITING

    Seoul, 110-744, South Korea

  • Research Site

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Research Site

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Research Site

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Research Site

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Research Site

    SUSPENDED

    Newcastle, NE7 7DN, United Kingdom

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