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Clinical Trials in the UK / NCT07064122
Recruiting Phase 1

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

NCT07064122 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 1
Started
2025-11-03
Last updated
2026-03-02

Condition(s) studied

Haematologic Neoplasms

Investigational drug(s) / intervention(s)

AZD2962

AZD2962: AZD2962 will be administered orally once daily.

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

Sex
ALL
Min age
18 Years
Max age
110 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Research Site Miami Florida Not Yet Recruiting
Research Site Tampa Florida Recruiting
Research Site Houston Texas Recruiting
Research Site Heidelberg Australia Recruiting
Research Site Melbourne Australia Recruiting
Research Site Shinagawa-ku Japan Recruiting
Research Site Yoshida-gun Japan Recruiting
Research Site Seoul South Korea Withdrawn
Research Site Seoul South Korea Withdrawn
Research Site Barcelona Spain Recruiting
Research Site Madrid Spain Recruiting
Research Site Madrid Spain Recruiting
Research Site Pamplona Spain Recruiting
Research Site Salamanca Spain Recruiting
Research Site Valencia Spain Withdrawn
Research Site Kaohsiung City Taiwan Not Yet Recruiting
Research Site Tainan Taiwan Not Yet Recruiting
Research Site Taipei Taiwan Recruiting
Research Site London United Kingdom Recruiting
Research Site London United Kingdom Recruiting
Research Site Manchester United Kingdom Recruiting

More AstraZeneca trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07064122 on ClinicalTrials.gov ↗ ← All trials in the UK