Actively Recruiting
A Phase Ib/II Study of APG-115 Combined With PD-1 Inhibitor Toripalimab in Patients With Advanced Liposarcoma or Other Advanced Solid Tumors
Led by Ascentage Pharma Group Inc. · Updated on 2025-02-26
95
Participants Needed
3
Research Sites
39 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
Researchers are evaluating APG-115 combined with the PD-1 inhibitor toripalimab in patients with advanced liposarcoma or other advanced solid tumors. The study includes a Phase Ib dose-escalation part to find the maximum tolerated dose (MTD) of APG-115 with toripalimab, followed by a Phase II portion that assesses the treatment's clinical effectiveness and safety in advanced liposarcoma. The trial uses a Simon two-stage design to test response rates, aiming to determine if the combination therapy shows promising activity. In the first part, APG-115 will be given orally every other day at doses of 50mg, 100mg, 150mg, or 200mg for two weeks with one week off, forming a 3-week cycle. Toripalimab will be administered intravenously at the approved dose of 240mg on Day 1 of each 3-week cycle. The second part administers the recommended Phase II dose (RP2D) of APG-115 with toripalimab to about 34 patients, continuing treatment until disease progression or unacceptable toxicity occurs. Participants will undergo assessments including measuring dose-limiting toxicities over 21 days and overall response rates up to 12 months. Evaluations include imaging scans to measure tumors, lab tests for organ function, and monitoring for adverse effects. Treatment response and safety will be closely tracked throughout the study, which may last several months depending on individual patient outcomes.
CONDITIONS
Brief 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 0-1
- Phase Ib: Histologically confirmed advanced liposarcoma or advanced solid tumor patients who failed standard therapy
- Phase II: Histologically confirmed advanced liposarcoma with TP53 wild-type and MDM2 amplification
- Expected survival longer than 12 weeks
- Measurable disease by CT or MRI according to RECIST 1.1
- Adequate bone marrow and organ function without ongoing supportive treatment, 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 (≤5 times if hepatic metastases), and serum creatinine ≤1.5 times upper limit or creatinine clearance ≥50 ml/min
You will not qualify if you...
- Prior treatment with MDM2-p53 inhibitors
- Known hypersensitivity to PD-(L)1 inhibitors or prior grade 3 or higher immune-related adverse events
- Previous immunotherapy including PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, or OX-40 (for phase II)
- Active central nervous system metastases or carcinomatous meningitis
- Active or history of autoimmune disease
- Active infection or unexplained fever over 38.5 °C within two weeks before first dose
- Severe or uncontrolled diseases including uncontrolled hypertension, significant cardiovascular or cerebrovascular disease, congestive heart failure NYHA class >2, serious infections, pulmonary disease, moderate to severe liver or kidney impairment, psychiatric illness impacting compliance
- Poorly controlled arrhythmia, including QTc interval >450 ms for males and >470 ms for females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive APG-115 orally every other day for 2 weeks followed by 1 week off, combined with intravenous toripalimab administered once every 3 weeks, in repeated 3-week cycles.
Visits every 3 weeks for treatment administration and assessment
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
G
Guojuan Chen, MD.
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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