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

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female patients age ≥18 years on day of signingthe informed consent;

2. ECOG PS 0-1;

3. Phase Ib: Histologically confirmed, advanced liposarcoma or advanced solid tumorpatients 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 laboratoryvalues without continuous supportive treatment (such as blood transfusion,coagulation factors and/or platelet infusion, red/white blood cell growth factoradministration, or albumin infusion)

7. ANC≥1.5 x 10^9/ L;

8. PLT≥100 x 10^9/ L;

9. Hgb≥90 g/L;

10. Alb≥30 g/L;

11. AST and AST ≤3 * ULN (for hepatic metastases, ALT and AST≤5*ULN);

12. 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 anduncontrollable levels of normal anti-hypertensive medication; clinically significantcardiovascular and cerebrovascular diseases, including but not limited to severeacute myocardial infarction, unstable or severe angina, or coronary artery bypasssurgery, congestive heart failure (New York Heart Association (NYHA) ) > 2);activeor uncontrolled serious infection (≥CTCAE 5.0 Level 2 infection);objective evidenceof previous or current history of pulmonary disease; moderate to severe hepaticimpairment (Child-Pugh score ≥ 10 points); moderate to severe renal impairment orpsychiatric illness/social circumstances that may affect study compliance;

8. Poorly controlled arrhythmia (including QTc interval ≥450 ms for males and ≥470 msfor females).