drugset / Trial / NCT04785196
APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
Phase 1/2
Recruiting
95 enrolled
Ascentage Pharma Group Inc.
Suzhou Yasheng Pharmaceutical Co., Ltd. · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-05-26
- Primary completion
- 2026-04
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alrizomadlin | Small molecule | 50 mg | Oral |
| Subject | Alrizomadlin | Small molecule | 100 mg | Oral |
| Subject | Alrizomadlin | Small molecule | 150 mg | Oral |
| Subject | Alrizomadlin | Small molecule | 200 mg | Oral |
| Background | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |