Phase Ib Study of Oral Rezatapopt with Intravenous Azacitidine for Adults with TP53Y220C Mutant Acute Myeloid Leukemia or Myelodysplastic Syndrome

What this Trial Is About

Researchers are evaluating rezatapopt combined with azacitidine in patients with TP53Y220C-mutant myeloid malignancies, including acute myeloid leukemia AML and myelodysplastic syndrome MDS. This phase Ib study aims to assess the safety and tolerability of rezatapopt and also looks at its clinical effectiveness, event-free survival, overall survival, and duration of response in both newly diagnosed and relapsed or refractory patients. The study also explores genetic changes related to TP53Y220C mutations and immunologic profiles. Participants receive oral rezatapopt daily along with intravenous azacitidine for 7 days in each treatment cycle. Treatment is administered either in an inpatient or outpatient setting. The study focuses on adults with confirmed TP53Y220C mutations and specific classifications of MDS. The design is a single-group, non-randomized treatment study. Throughout the study, participants are closely monitored for safety and adverse events over about one year. Assessments include genetic sequencing of bone marrow samples, evaluation of mutation changes, and immunologic markers. Participants must adhere to visit schedules and undergo laboratory tests to evaluate organ function and treatment response. The total study duration extends up to August 2029, ensuring long-term follow-up and data collection.

A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)