Safety and Dose Study of Oral CHM-029 in Adults with Relapsed or Refractory AML Having NPM1 Mutation, KMT2A, or NUP98 Rearrangements

What this Trial Is About

Researchers are studying CHM-029, an investigational oral medicine, in adults with relapsed or refractory acute myeloid leukemia AML who have specific genetic changes including NPM1 mutation, KMT2A rearrangement, or NUP98 rearrangement. This Phase 12, open-label, multicenter study aims to evaluate the safety, tolerability, how the body processes CHM-029, and its preliminary anti-leukemia activity. The study focuses on finding the appropriate dose and understanding potential side effects. Participants will receive CHM-029 by mouth at increasing dose levels based on safety reviews. The study includes two groups one undergoing dose escalation to determine safe doses and another receiving doses already evaluated for safety. Researchers will monitor participants closely to assess dose-limiting toxicities and adjust treatment accordingly. During the study, participants will have regular visits for safety assessments, blood tests, electrocardiograms ECGs, and bone marrow evaluations to monitor health and treatment response. Researchers will track adverse events, laboratory abnormalities, and pharmacokinetics over an average of three years. The study aims to identify the maximum tolerated or optimal biological dose while measuring remission rates and survival outcomes.

A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML