Home › Trials › NCT07064122

AZD2962 (IRAK4 blocker) for relapsed MDS and dysplastic CMML

A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AZD2962, an IRAK4 Inhibitor, as Monotherapy and in Combination With Other Agents, in Participants With Haematologic Neoplasms

Phase 1 Interventional AstraZeneca · NCT07064122

This trial will test whether the oral drug AZD2962, which blocks IRAK4, is safe and can help adults with relapsed or refractory myelodysplastic syndromes (MDS) or dysplastic chronic myelomonocytic leukemia (CMML).

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment72 (estimated)
Ages18 Years to 110 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsprednisone
Locations21 sites (Miami, Florida and 20 other locations)
Trial IDNCT07064122 on ClinicalTrials.gov

What this trial studies

This modular Phase 1 program begins with a dose-escalation module of AZD2962 given orally once daily in 28-day cycles to determine safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of efficacy. Eligible participants are adults with relapsed/refractory MDS or dysplastic CMML with <20% blasts, ECOG performance status ≤2, and prior lines of therapy. Treatment continues until disease progression, unacceptable toxicity, or withdrawal, with a screening period up to 21 days and a safety follow-up 30 days after the last dose. Key assessments include regular safety labs, PK/PD sampling, and bone marrow evaluations to measure response.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory MDS or dysplastic CMML (bone marrow or peripheral blasts <20%), symptomatic disease requiring therapy, ECOG ≤2, at least one prior line of treatment, and willingness to undergo baseline and on-study bone marrow sampling.

Not a fit: Patients with very advanced disease (≥20% blasts consistent with acute leukemia), poor performance status (ECOG >2), uncontrolled comorbidities or active infections, or who are pregnant are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, AZD2962 could offer a new targeted oral option that produces clinical responses or delays progression in patients with relapsed/refractory MDS or dysplastic CMML.

How similar studies have performed: Early-phase programs of other IRAK4 inhibitors and related pathway-targeted agents have shown preliminary signals of activity in some myeloid malignancies, but clinical benefit remains investigational and not yet established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts \< 20%, and who received one or more prior lines of therapy as per standard of care (or who exhausted locally available treatments including treatments for actionable mutations). Diagnosis must be histologically confirmed as per the WHO 2016 classification of myeloid neoplasms.
2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
3. Participants must have symptomatic disease that requires therapy and allows for objective 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 with local regulations and also comply with Clinical Study Protocol requirements.
6. All women of childbearing potential must have a negative serum pregnancy test result at Screening.

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 to first dose.
3. Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
4. Received major surgery within 28 days prior to first dose, or still recovering from surgery.
5. Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes, within 15 days prior to first dose.
6. Received immunosuppressive medications (including Graft-Versus-Host Disease prophylaxis) within 28 days prior to first dose, or within 15 days in the case of systemic 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 laboratory finding that make undesirable the participation in the study.

15\. 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.

16\. 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.

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

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

Where this trial is running

Miami, Florida and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Haematologic NeoplasmsInterleukin-1 receptor associated kinase 4 inhibitorModular studyPharmacokineticsDose escalation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.