NCT07064122

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a modular study. In Module 1, the study will begin with a dose escalation of AZD2962 monotherapy in participants with myelodysplastic syndromes (MDS) and dysplastic chronic myelomonocytic leukemia (CMML). Module 1 of the study will comprise of: 1. A Screening Period of maximum 21 days. 2. Treatment period with 28-day cycles where each patient will receive an oral dose of AZD2962 once daily, starting on Day 1, and will continue treatment until disease progression, unacceptable toxicity, or withdrawal. 3. Safety Follow-up period after 30 days after last dose.

Conditions

• Haematologic Neoplasms

Interventions

Type	Name	Description
DRUG	AZD2962	AZD2962 will be administered orally once daily.

Timeline

• Start date: 2025-11-03
• Primary completion: 2028-10-20
• Completion: 2028-10-20
• First posted: 2025-07-14
• Last updated: 2026-03-02

Locations

21 sites across 7 countries: United States, Australia, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study