A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)

Last updated: February 27, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Hematologic Neoplasms

Treatment

AZD2962

Clinical Study ID

NCT07064122
D7770C00001
172349
2025-520786-44
  • Ages 18-110
  • All Genders

Study Summary

The purpose of the study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD2962, an Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor, as monotherapy and in combination with other agents in participants with haematologic neoplasms.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Participants with relapsed/refractory MDS or participants with relapsed/refractorydysplastic CMML, with peripheral blasts or bone marrow blasts < 20%, and whoreceived one or more prior lines of therapy as per standard of care (or whoexhausted locally available treatments including treatments for actionablemutations). Diagnosis must be histologically confirmed as per the WHO 2016classification of myeloid neoplasms.

  2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

  3. Participants must have symptomatic disease that requires therapy and allows forobjective efficacy assessments.

  4. Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).

  5. Contraceptive use by participants or participant partners should be consistent withlocal regulations and also comply with Clinical Study Protocol requirements.

  6. All women of childbearing potential must have a negative serum pregnancy test resultat Screening.

Exclusion

Key Exclusion Criteria:

  1. Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.

  2. Received any antineoplastic therapy (except hydroxyurea) within 15 days prior tofirst dose.

  3. Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 daysprior to first dose.

  4. Received major surgery within 28 days prior to first dose, or still recovering fromsurgery.

  5. Received drugs that are known to prolong corrected QT interval (QTc) and with knownrisk of Torsades de Pointes, within 15 days prior to first dose.

  6. Received immunosuppressive medications (including Graft-Versus-Host Diseaseprophylaxis) within 28 days prior to first dose, or within 15 days in the case ofsystemic steroids (doses exceeding 10 mg/day of prednisone or equivalent).

  7. Received live attenuated vaccines within 28 days prior to first dose.

  8. Active major bleeding event.

  9. Any evidence of systemic disease, significant clinical disorder, or laboratoryfinding that make undesirable the participation in the study.

  10. Mean resting corrected QT interval using Fridericia's formula (QTcF) > 450 ms obtained from triplicate Electrocardiograms (ECGs) and averaged, recorded within 5 minutes. In the presence of bundle branch block, QTcF > 470 ms is applicable.

  11. History of intracranial bleeding within 6 months prior to first dose. 17. Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism or excretion of oral therapy.

  12. History of a prior non-haematologic neoplasm (with some exceptions). 19. Unresolved Grade > 2 toxicities from prior anticancer therapies (with some exceptions).

  13. Concurrent enrolment in another clinical study (with some exceptions). 21. Known hypersensitivity to study intervention or its excipients.

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: AZD2962
Phase: 1
Study Start date:
November 03, 2025
Estimated Completion Date:
October 20, 2028

Study Description

This is a modular study. In Module 1, the study will begin with a dose escalation of AZD2962 monotherapy in participants with myelodysplastic syndromes (MDS) and dysplastic chronic myelomonocytic leukemia (CMML).

Module 1 of the study will comprise of:

  1. A Screening Period of maximum 21 days.

  2. Treatment period with 28-day cycles where each patient will receive an oral dose of AZD2962 once daily, starting on Day 1, and will continue treatment until disease progression, unacceptable toxicity, or withdrawal.

  3. Safety Follow-up period after 30 days after last dose.

Connect with a study center

  • Research Site

    Heidelberg, 3084
    Australia

    Site Not Available

  • Research Site

    Heidelberg 2163654, 3084
    Australia

    Active - Recruiting

  • Research Site

    Melbourne, 3000
    Australia

    Site Not Available

  • Research Site

    Melbourne 2158177, 3000
    Australia

    Active - Recruiting

  • Research Site

    Shinagawa-ku, 141-0022
    Japan

    Active - Recruiting

  • Research Site

    Yoshida-gun, 910-1193
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Research Site

    Barcelona, 08035
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28033
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28027
    Spain

    Active - Recruiting

  • Research Site

    Pamplona, 31008
    Spain

    Site Not Available

  • Research Site

    Pamplona 3114472, 31008
    Spain

    Active - Recruiting

  • Research Site

    Salamanca, 37007
    Spain

    Site Not Available

  • Research Site

    Salamanca 3111108, 37007
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46026
    Spain

    Site Not Available

  • Research Site

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Research Site

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City 1673820, 83301
    Taiwan

    Site Not Available

  • Research Site

    Tainan 1668355, 70403
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 100
    Taiwan

    Active - Recruiting

  • Research Site

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • Research Site

    London 2643743, W1T 7HA
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Manchester 2643123, M20 4BX
    United Kingdom

    Active - Recruiting

  • Research Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Research Site

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Research Site

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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