NCT07064122 · AstraZeneca
A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)
What this study is about
The purpose of the study to evaluate the safety, tolerability, how the drug moves through the body (PK), how the drug affects the body, and preliminary effectiveness of AZD2962, an Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor, as treatment given alone and in combination with other agents in participants with haematologic neoplasms.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Participants must have symptomatic disease that requires therapy and allows for objective efficacy assessments.
- Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
- Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol requirements.
- All women of childbearing potential must have a negative serum pregnancy test result at Screening. Key
Exclusion criteria
- Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
- Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
- Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
- Received major surgery within 28 days prior to first dose, or still recovering from surgery.
- 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.
- 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).
- Received live attenuated vaccines within 28 days prior to first dose.
- Active major bleeding event.
- 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
- Miami, Florida
- Tampa, Florida
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations