Phase I Study of Cirtuvivint Alone and With ASTX727 for Treating Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes

What this Trial Is About

This research aims to evaluate the safety, side effects, and best dose of SM08502 cirtuvivint alone and combined with ASTX727 in patients with acute myeloid leukemia AML and myelodysplastic syndromes MDS. The study focuses on relapsed or refractory AML and MDS, as well as frontline high-risk MDS. Cirtuvivint may work by blocking enzymes needed for cancer cell growth, while ASTX727 combines decitabine and cedazuridine to help bone marrow produce normal blood cells and kill abnormal cells. This phase I trial explores how these treatments affect patients, including their safety and potential anti-tumor activity. Participants are divided into three groups receiving different schedules of oral cirtuvivint Cohort I receives the drug daily on days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle Cohort II receives it on days 1, 4, 8, 11, 15, 18, 22, and 25 and Cohort III receives the same cirtuvivint schedule as Cohort II plus ASTX727 on days 1-5. These cycles repeat every 28 days unless disease progression or unacceptable toxicity occurs. Before treatment, patients undergo heart function tests echocardiography or MUGA scan and blood and bone marrow sample collections. During the study, patients continue blood and bone marrow sampling to monitor their response and safety. After treatment, they are followed for 30 days, then every three months for two years, and every six months for up to three more years. Researchers measure the maximum tolerated dose, recommended phase 2 dose, adverse events, clinical response, event-free survival, and overall survival. This comprehensive monitoring helps evaluate the treatments effects and guide future development.

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes