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

Trial Details

NCT ID

NCT04785196

Phase

PHASE1 / PHASE2

Sponsor

Ascentage Pharma Group Inc.

Status

RECRUITING

Cancer Type

Sarcoma

Interventions

APG-115
Toripalimab

Locations (sample)

Guangzhou, Guangdong, China|23.11667,113.25
Hangzhou, Zhejiang, China|30.29365,120.16142
Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

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: Histologic…
The expected survival period is more than 12 weeks;

For full eligibility, visit ClinicalTrials.gov.

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