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

An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy

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.