A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Hae… (NCT07064122) | Clinical Trial Compass
RecruitingPhase 1
A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)
United States, Australia72 participantsStarted 2025-11-03
Plain-language 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.
Who can participate
Age range18 Years – 110 Years
SexALL
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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.
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.
What they're measuring
1
Number of participants with dose limiting toxicity (DLT)
Timeframe: From Cycle 1 Day 1 up to end of Cycle 1 (28 Days)
2
Number of participants with Adverse events (AEs) and serious AEs
Timeframe: Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)
3
Duration of exposure
Timeframe: Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)
4
Relative dose intensity
Timeframe: Cycle 1 Day 1 up to safety follow-up (30 days after last dose) (Approximately 3 years)
. 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.