RecruitingPhase 1Phase 2NCT04785196

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

A Phase Ib/II Study of APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Other Advanced Solid Tumors

Sponsor

Ascentage Pharma Group Inc.

Enrollment

95 participants

Start Date

May 26, 2021

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Liposarcoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called APG-115 (a drug that reactivates a tumor-suppressing protein called p53) combined with an anti-PD-1 immunotherapy drug for people with advanced liposarcoma (a fat tissue cancer) or other advanced solid tumors. The Phase II portion focuses specifically on liposarcoma with a specific genetic profile. **You may be eligible if...** - You are 18 or older with confirmed advanced liposarcoma or another advanced solid tumor (Phase Ib), OR confirmed advanced liposarcoma with TP53 wild-type and MDM2 amplification (Phase II) - Standard treatments have already failed - Your life expectancy is more than 12 weeks - You have measurable disease on CT or MRI - You are in good health overall (ECOG 0–1) with adequate blood counts and organ function **You may NOT be eligible if...** - Your tumor has a TP53 mutation (for Phase II) - You have active autoimmune disease - You have active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPG-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.

DRUGToripalimab

Toripalimab is administrated following CDE approved label dose, i.e.: 240 mg intravenous infusion at Day 1 of every 3 weeks as a cycle.