Phase I Evaluation of BMS-986497 Monotherapy and in Combination with Azacitidine and Azacitidine Plus Venetoclax in Relapsed/Refractory AML or MDS

The primary objective of this phase I study is to evaluate the safety and pharmacokinetics of BMS-986497 administered as a monotherapy or in combination with azacitidine or in combination with both azacitidine and venetoclax in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. This assessment is clinically relevant for determining the tolerable dose levels and metabolic profiles of the investigational agent in heavily pretreated populations.

This clinical trial involves a total of 70 patients. The study population includes both male and female individuals. Participants are identified by age range codes 3 and 4. The subjects are diagnosed with acute myeloid leukemia and myelodysplastic syndrome. The sponsor did not provide additional information regarding lifestyle considerations or specific selection methodologies.

This Phase I clinical trial is designed to evaluate the safety and efficacy of BMS-986497 administered as a monotherapy, in combination with azacitidine, or in combination with both azacitidine and venetoclax in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. The study follows a systematic research methodology involving a screening visit to determine eligibility. Subsequent follow-up visits and an end-of-study visit are scheduled to monitor clinical outcomes and safety profiles. The total duration of the study is expected to continue until the estimated completion in late 2028. Participants may undergo early termination of study involvement based on specific clinical criteria or safety protocols.

The efficacy assessment in this Phase 1 clinical trial is focused on patients diagnosed with acute myeloid leukemia and myelodysplastic syndrome.