Phase 11b Study of Oral BH-30236 Alone or with Venetoclax for Adults With Relapsed or Refractory Acute Myelogenous Leukemia or Higher-Risk Myelodysplastic Syndrome

What this Trial Is About

Researchers are studying BH-30236, a new oral drug, in adults with relapsed or refractory acute myelogenous leukemia RR AML or higher-risk myelodysplastic syndrome HR-MDS. This Phase 11b, open-label trial aims to assess the safety, tolerability, how the body processes the drug pharmacokinetics and pharmacodynamics, and preliminary anti-leukemic effects. The study is sponsored by BlossomHill Therapeutics and involves participants who have had 1 to 5 prior treatments and meet specific health criteria. The trial includes three parts Phase 1 Part 1 tests BH-30236 alone in ascending doses to identify safe dosage levels. Phase 1 Part 2 evaluates BH-30236 combined with venetoclax, another oral drug, also in increasing doses. The Phase 1b Dose Expansion enrolls participants to further study the safety and early effectiveness of BH-30236 alone or with venetoclax at selected dose levels from earlier phases. Participants will take BH-30236 tablets orally at assigned dose levels, with venetoclax tablets added in combination groups. Safety is closely monitored through treatment-related adverse events and dose-limiting toxicities during the first 28-day cycle. Researchers will also assess remission rates and other measures of anti-leukemic activity for up to approximately one year. The study tracks drug blood levels, response duration, time to remission, and changes in RNA markers to understand treatment impact and tolerability.

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome