APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
APG-115: Dose escalation of APG-115 in combination with label dose of toripalimab, four dose levels of APG-115 will be tested: 50, 100, 150, and 200mg. APG-115 will be administrated orally every other day (QOD) for consecutive 2 weeks (ie. dosed at Day 1, 3, 5, 7, 9, 11, and 13), with one week dosing off as 3 weeks a cycle.
Toripalimab: Toripalimab is administrated following CDE approved label dose, i.e.: 240 mg intravenous infusion at Day 1 of every 3 weeks as a cycle.
Study 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.
Eligibility
Primary outcome measure(s)
- Dose Limiting Toxicity (Phase I) — 21 days
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 3 weeks of study treatment. These will be assessed via CTCAE version 5.0. - Recommended Phase II Dose — 21 days
Phase I is aimed to generate data to select the recommended Phase II dose. - Overall Response Rate (Phase II) — up to 12 months
Phase II is to assess overall response rate of APG-115 in combination with toripalimab defined as the percentage of subjects with a best overall confirmed CR or a PR at any time as per RECIST v1.1.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| Cancer Hospital of The University of Chinese Academy of Sciences | Hangzhou | Zhejiang | Not Yet Recruiting |
| Shanghai East Hospital (East Hospital affiliated to Tongji University) | Shanghai | China | Recruiting |
More Ascentage Pharma Group Inc. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04785196 on ClinicalTrials.gov ↗ ← All trials in China