Actively Recruiting
APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
Led by Ascentage Pharma Group Inc. · Updated on 2025-02-26
95
Participants Needed
3
Research Sites
292 weeks
Total Duration
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
S
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant, non-lactating female patients aged 18 years or older
- ECOG Performance Status of 0 or 1
- Phase Ib: Histologically confirmed advanced liposarcoma or advanced solid tumor after failure of standard therapy
- Phase II: Histologically confirmed advanced liposarcoma with TP53 wild-type and MDM2 amplification
- Expected survival longer than 12 weeks
- Measurable disease on CT or MRI by RECIST 1.1 criteria
- Adequate bone marrow and organ function without ongoing supportive treatments, including ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L, albumin ≥ 30 g/L, AST and ALT ≤ 3 times upper limit of normal (or ≤ 5 times for hepatic metastases), serum creatinine ≤ 1.5 times upper limit or creatinine clearance ≥ 50 ml/min
You will not qualify if you...
- Prior treatment with any MDM2-p53 inhibitor
- Known hypersensitivity to PD-(L)1 inhibitors or history of severe immune-related adverse events (grade 3 or higher)
- Prior immunotherapy including PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, or OX-40 antibodies (for Phase II)
- Active central nervous system metastases or carcinomatous meningitis
- Active or history of autoimmune disease
- Active infection or unexplained fever above 38.5°C within two weeks before first dose
- Severe or uncontrolled diseases including uncontrolled hypertension, significant cardiovascular or cerebrovascular disease, congestive heart failure above NYHA class 2, serious infections, pulmonary disease, moderate to severe liver impairment, moderate to severe kidney impairment, or psychiatric/social conditions affecting compliance
- Poorly controlled arrhythmia including prolonged QTc interval (>450 ms for males, >470 ms for females)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
3
Shanghai East Hospital (East Hospital affiliated to Tongji University)
Shanghai, China
Actively Recruiting
Research Team
Y
Yifan Zhai, MD, PhD
CONTACT
G
Guojuan Chen, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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