APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors

Launched by ASCENTAGE PHARMA GROUP INC. · Mar 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for patients with advanced liposarcoma or other advanced solid tumors. The researchers are testing a drug called APG-115 along with another medication known as a PD-1 inhibitor (toripalimab) to see if this combination is safe and effective. The trial has two parts: the first part aims to find the highest safe dose of APG-115, while the second part will treat about 34 patients with advanced liposarcoma to see how well the combination works over time.

To be eligible for this trial, participants should be at least 18 years old and have a confirmed diagnosis of advanced liposarcoma or solid tumors that have not responded to standard treatments. They should also be in generally good health and have measurable disease that can be tracked through imaging tests. Patients who have had certain previous treatments or have specific health conditions may not qualify. Those who participate will receive the combination therapy until their cancer progresses or if they experience unacceptable side effects. This trial is currently recruiting participants, and it offers an opportunity for patients seeking new treatment options for their condition.

Gender

ALL

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).