Phase 1 Study of ICP-248 and Azacitidine for Treating Adults with Acute Myelogenous Leukemia and Myelodysplastic Syndromes

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes, and early effects of ICP-248 combined with azacitidine in patients with acute myelogenous leukemia AML and myelodysplastic syndromes MDS. The study focuses on these blood cancers to better understand potential treatment options. This is a phase 1 clinical trial sponsored by Beijing InnoCare Pharma Tech Co., Ltd. aimed at determining appropriate dosing and monitoring adverse effects. Participants will receive ICP-248 orally once daily in 28-day treatment cycles. Alongside, azacitidine will be given either by injection under the skin or into a vein once daily on days 1 through 7 of each cycle. The study will track responses in two groups those with AML and those with MDS, observing remission rates and other clinical responses over about 2.5 years. During the study, participants will undergo regular assessments for side effects using standard criteria, blood tests to measure drug levels, and evaluations of disease response. The main outcomes include the rate and severity of treatment-related toxicities, remission rates, and survival measures. This careful monitoring will last for approximately 2.5 years to gather detailed information about the treatments impact and safety.

ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies