Study of APG-115 Combined With Toripalimab for Treating Advanced Liposarcoma or Other Advanced Solid Tumors Phase IbII Drug Trial to Find Safe Dose and Test Effectiveness

What this Trial Is About

Researchers are evaluating APG-115 combined with the PD-1 inhibitor toripalimab in patients with advanced liposarcoma or other advanced solid tumors. The study includes a Phase Ib dose-escalation part to find the maximum tolerated dose MTD of APG-115 with toripalimab, followed by a Phase II portion that assesses the treatments clinical effectiveness and safety in advanced liposarcoma. The trial uses a Simon two-stage design to test response rates, aiming to determine if the combination therapy shows promising activity. In the first part, APG-115 will be given orally every other day at doses of 50mg, 100mg, 150mg, or 200mg for two weeks with one week off, forming a 3-week cycle. Toripalimab will be administered intravenously at the approved dose of 240mg on Day 1 of each 3-week cycle. The second part administers the recommended Phase II dose RP2D of APG-115 with toripalimab to about 34 patients, continuing treatment until disease progression or unacceptable toxicity occurs. Participants will undergo assessments including measuring dose-limiting toxicities over 21 days and overall response rates up to 12 months. Evaluations include imaging scans to measure tumors, lab tests for organ function, and monitoring for adverse effects. Treatment response and safety will be closely tracked throughout the study, which may last several months depending on individual patient outcomes.

APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors