Clinical Trial

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

Recruiting Phase 1/2
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Record status
This record was last updated February 26, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
Part 1 is a phase Ib standard "3 + 3" design, will be employed to determine the MTD of APG-115 by assessing the DLT of APG-115 in combination with PD-1 inhibitor(toripalimab) in advanced solid tumors. Part 2 is a Simon two-stage phase II study design. At RP2D of APG-115 in combination with toripalimab in advanced liposarcoma, approximately 34 patients will be treated with the combination until disease progression, unacceptable toxicity, or another discontinuation criterion is met.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-03-02; most recent amendment 2025-02-24.
Status change: Not Yet Recruiting → Recruiting 2021-06-03
Trial Details
NCT Number NCT04785196
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions Liposarcoma, Advanced Solid Tumor
Enrollment 95 participants
Start Date 2021-05-26
Primary Completion 2026-04 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-26