Phase I Study of Oral APG-2575 for Safety and Effectiveness in Adults with Blood Cancers

What this Trial Is About

Researchers are evaluating APG-2575, an oral drug, in patients with hematologic malignancies such as multiple myeloma, chronic lymphocytic leukemia, and other B-cell cancers. This early phase 1 trial aims to study the safety, tolerability, and how the drug behaves in the body. The study includes both a dose escalation stage and a dose expansion stage to find the best dose for patients who have relapsed or are refractory to other treatments. APG-2575 is given as an oral tablet once daily for 4-week cycles, starting at 20 mg with increasing doses in subsequent patient groups up to 800 mg. Dose escalation follows a specific plan with monitoring for side effects, and once the maximum tolerated dose MTD is determined, up to 20 patients will receive that dose in the expansion phase. The study is open-label, meaning all participants receive the drug, not a placebo. Participants will have regular assessments including blood tests to monitor drug levels, side effects, and anti-tumor effects, with safety and drug behavior measured over 28 days. The study also evaluates longer-term anti-tumor responses up to 2 years. Patients are monitored closely for any toxicities, and the total participation time varies depending on treatment response and tolerability. This study is sponsored by Ascentage Pharma Group Inc.

APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic Malignancies