Combining APG-115 with PD-1 inhibitor for advanced liposarcoma and solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of APG-115 in combination with the PD-1 inhibitor toripalimab in patients with advanced liposarcoma or other advanced solid tumors. The study is divided into two parts: the first part aims to determine the maximum tolerated dose (MTD) of APG-115 using a dose-escalation approach, while the second part evaluates the clinical efficacy of the established dose in a larger cohort of patients. Participants will be monitored for disease progression and treatment-related toxicities throughout the trial.

Why it matters

Who can join: the full rules

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).

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Shanghai East Hospital (East Hospital affiliated to Tongji University)
  Shanghai, China Recruiting
• Cancer Hospital of The University of Chinese Academy of Sciences
  Hangzhou, Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Ye Guo, MD, PhD — Shanghai East Hospital
• Study coordinator: Yifan Zhai, MD, PhD
• Email: Yzhai@ascentage.com
• Phone: +86-20-28068501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.