Clinical Trial 23620

• Overview

  Study Title:

  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

  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.

  Objective:

  Primary Objective: This study will assess the safety, tolerability, and efficacy of AZD2962, and characterise its PK profile in monotherapy and in combination in haematologic neoplasms. Secondary Objective: N/A

• Treatments

  Therapies:

  Selective small molecule inhibitor of IRAK4

  Medications:

  AZD2962 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts > 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.
  • Additional criteria may apply.

• Exclusion Criteria

  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.
  • Additional criteria may apply.

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