APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
Recruiting
Phase 1
Phase 2
Interventional Study
Liposarcoma
Advanced Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 95 (estimated)
- Sponsor
- Ascentage Pharma Group Inc. · Industry
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About This Trial
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 di…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent;
2. ECOG PS 0-1;
3. Phase Ib: Histologically confirmed, advanced liposarcoma or advanced solid tumor patients who failed standard of care therapy; Phase II: Histologically…
Contacts