Phase 12 Study to Evaluate Safety and Effectiveness of Daily Intravenous AB8939 for Adults With Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and tolerability of AB8939 in patients with relapsed or refractory acute myeloid leukemia AML and refractory myelodysplastic syndrome. This Phase 12, open-label study aims to determine dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for further studies, as well as to provide an early assessment of AB8939s effects. The study has two parts a dose escalation phase and a dose expansion phase. In the first part, AB8939 is given intravenously daily to patients to assess safety, tolerability, and pharmacokinetics, with doses starting at 0.9 mgm. The second part evaluates the recommended dose and schedule for a Phase 2 trial. AB8939 is studied both alone and in combination with venetoclax, which is given according to an escalating dose schedule. Participants will undergo regular assessments including bone marrow biopsies and clinical evaluations to monitor safety and response. Researchers will measure dose-limiting toxicities within 56 days as the primary outcome and assess objective response rates as a secondary outcome. The study includes ongoing monitoring and treatment over the study period, with participation lasting as defined by the treatment and follow-up schedule.

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia