OncoMatch/Clinical Trials/NCT04785196
APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
Is NCT04785196 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including APG-115 and Toripalimab for liposarcoma.
Treatment: APG-115 · Toripalimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Tumor Agnostic
Biomarker criteria
Required: MDM2 amplification
Required: TP53 wild-type
Disease stage
Metastatic disease required
advanced liposarcoma or advanced solid tumor patients who failed standard of care therapy; ... Measurable disease on CT or MRI by RECIST 1.1.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care therapy
patients who failed standard of care therapy
Cannot have received: MDM2-p53 inhibitor
Patients who have previously been treated with MDM2-p53 inhibitor
Cannot have received: immunotherapy (PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, OX-40)
Exception: for phase II
Prior treatment consisted of any kinds of immunotherapies, like PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, OX-40 et.al( for phase II)
Lab requirements
Blood counts
ANC≥1.5 x 10^9/ L; PLT≥100 x 10^9/ L; Hgb≥90 g/L; Alb≥30 g/L
Kidney function
Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 50ml / min
Liver function
AST and ALT ≤3 * ULN (for hepatic metastases, ALT and AST≤5*ULN)
Adequate bone marrow and organ function as indicated by: ... laboratory values without continuous supportive treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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