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

• Status: Recruiting
• Trial end date: 2024-11-20
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Criteria

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.