NCT04785196 APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
| NCT ID | NCT04785196 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ascentage Pharma Group Inc. |
| Condition | Liposarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2021-05-26 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 95 participants in total. It began in 2021-05-26 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 confirmed, advanced liposarcoma with TP53 wide-type and MDM2 Amplification; 4. The expected survival period is more than 12 weeks; 5. Measurable disease on CT or MRI by RECIST 1.1. 6. Adequate bone marrow and organ function as indicated by: the following laboratory values without continuous supportive treatment (such as blood transfusion, coagulation factors and/or platelet infusion, red/white blood cell growth factor administration, or albumin infusion) 1. ANC≥1.5 x 10\^9/ L; 2. PLT≥100 x 10\^9/ L; 3. Hgb≥90 g/L; 4. Alb≥30 g/L; 5. AST and AST ≤3 \* ULN (for hepatic metastases, ALT and AST≤5\*ULN); 6. Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 50ml / min. Exclusion Criteria: 1. Patients who have previously been treated with MDM2-p53 inhibitor; 2. Known hypersensitivity reaction to PD-(L)1 inhibitors, or any prior ≥ Grade 3 irAE; 3. Prior treatment consisted of any kinds of immunotherapies, like PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, OX-40 et.al( for phase II); 4. Has known active central nervous (CNS) metastases and/or carcinomatous meningitis; 5. Has any active or history of autoimmune disease; 6. Active infection or unexplained fever \> 38.5 ° C two weeks before first dose; 7. Patients with any severe and/or uncontrolled diseases, including: hypertension and uncontrollable levels of normal anti-hypertensive medication; clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, or coronary artery bypass surgery, congestive heart failure (New York Heart Association (NYHA) ) \> 2);active or uncontrolled serious infection (≥CTCAE 5.0 Level 2 infection);objective evidence of previous or current history of pulmonary disease; moderate to severe hepatic impairment (Child-Pugh score ≥ 10 points); moderate to severe renal impairment or psychiatric illness/social circumstances that may affect study compliance; 8. Poorly controlled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females).
Contact & Investigator
Ye Guo, MD, PhD
PRINCIPAL INVESTIGATOR
Shanghai East Hospital
Frequently Asked Questions
Who can join the NCT04785196 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liposarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04785196 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04785196 currently recruiting?
Yes, NCT04785196 is actively recruiting participants. Contact the research team at Yzhai@ascentage.com for enrollment information.
Where is the NCT04785196 trial being conducted?
This trial is being conducted at Guangzhou, China, Hangzhou, China, Shanghai, China.
Who is sponsoring the NCT04785196 clinical trial?
NCT04785196 is sponsored by Ascentage Pharma Group Inc.. The principal investigator is Ye Guo, MD, PhD at Shanghai East Hospital. The trial plans to enroll 95 participants.