Phase III Study to Evaluate AZD2962, an IRAK4 Inhibitor, Alone and With Other Treatments in Adults With Blood Cancers

What this Trial Is About

Researchers are studying AZD2962, an IRAK4 inhibitor, to assess its safety, tolerability, how it acts in the body, and early signs of effectiveness in adults with blood cancers such as myelodysplastic syndromes MDS and dysplastic chronic myelomonocytic leukemia CMML. This Phase 12 open-label study aims to understand the potential of AZD2962 alone and in combination with other treatments for these hematologic neoplasms. The study starts with a dose escalation phase where participants receive AZD2962 as a monotherapy by taking an oral dose once daily in 28-day treatment cycles. The treatment continues until disease progression, unacceptable side effects, or participant withdrawal. The study includes a screening period lasting up to 21 days before treatment begins, followed by a safety follow-up period lasting 30 days after the last dose. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, and drug exposure levels throughout treatment and follow-up, which may last up to approximately three years. Researchers will also evaluate responses to treatment, time to disease progression, overall survival, and blood drug concentration levels. Study procedures include baseline bone marrow samples and frequent health evaluations to ensure safety and track treatment effects.

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