A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
Trial Parameters
Brief Summary
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-8068 injection in combination with anti-tumor therapies in subjects with colorectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks. 5. Need to provided tumor tissue samples for genetic testing. Exclusion Criteria: 1. Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis. 2. Part B: Systemic antitumor therapy was received 4 weeks before the start of the study. 3. Part B: Palliative radiotherapy was completed within 14 days before the first dose. 4. Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria. 5. Subjects with known or suspected interstitial pneumonia. 6. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusi