A Phase Ib/II Study of APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Other Advanced Solid Tumors
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.
• Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent;
• ECOG PS 0-1;
• Phase Ib: Histologically confirmed, advanced liposarcoma or advanced solid tumor patients who failed standard of care therapy; Phase II: Histologically confirmed, advanced liposarcoma with TP53 wide-type and MDM2 Amplification;
• The expected survival period is more than 12 weeks;
• Measurable disease on CT or MRI by RECIST 1.1.
• Adequate bone marrow and organ function as indicated by: the following laboratory values without continuous supportive treatment (such as blood transfusion, coagulation factors and/or platelet infusion, red/white blood cell growth factor administration, or albumin infusion)
‣ ANC≥1.5 x 10\^9/ L;
⁃ PLT≥100 x 10\^9/ L;
⁃ Hgb≥90 g/L;
⁃ Alb≥30 g/L;
⁃ AST and AST ≤3 \* ULN (for hepatic metastases, ALT and AST≤5\*ULN);
⁃ Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 50ml / min.