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.
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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

Yifan Zhai, MD, PhD

+86-20-28068501

Yzhai@ascentage.com

CONTACT

Guojuan Chen, MD.

+86-20-28068520

guojuan.chen@ascentage.com

CONTACT