Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas

Inclusion Criteria:

1. Age ≥18 years old, male or female
2. Life expectancy≥12 weeks;
3. Phase 1b: Patients with advanced solid tumors diagnosed by histology or cytology, who have been failure to previous standard treatments; Phase 2: Patients with HNSCC, NPC, OC, NSCLC, SCLC, HCC, cHL and other solid tumors diagnosed by histology or cytology, who have been failure to first-line standard treatment (including PD-1/L1) at least;
4. ECOG PS of 0 or 1;
5. Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation.
6. Adverse events associated with previous anti-tumor therapy have returned to≤ grade 1(NCI CTCAE V5.0);

Exclusion Criteria:

1. Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein;
2. Patients with symptomatic or progressive central nervous system (CNS) metastasis;
3. Uncontrolled hypertension, pulmonary hypertension or unstable angina, myocardial infarction within 6 months prior to administration; a history of chronic heart failure (NYHA G3/4); severe arrhythmia;
4. A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration;
5. A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency;
6. With other malignant tumors;
7. Diseases that may cause gastrointestinal bleeding or perforation;
8. Uncontrollable pleural, peritoneal or pericardial effusions;
9. A history of immunodeficiency;
10. A history of autoimmune diseases;
11. Uncontrolled severe active infections.