A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors

This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.

Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; 2. Age range: 18-75 years old, both male and female are welcome; 3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment; 4. Have at least one measurable tumor lesion per RECIST v1.1; 5. ECOG performance status of 0-1; 6. Life expectancy ≥ 12 weeks; 7. Adequate bone marrow and organ function. Exclusion Criteria: 1. Patients with active central nervous system metastases or meningeal metastases; 2. Systemic antitumor therapy was received 4 weeks before the start of the study; 3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion; 4. Have poorly controlled or severe cardiovascular disease; 5. Subjects with active hepatitis B or active hepatitis C; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.