A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer

Korábbi kezelés

• Part B: Systemic antitumor therapy was received 4 weeks before the start of the study.
• Part B: Palliative radiotherapy was completed within 14 days before the first dose.
• Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.

Más betegség

• Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
• Have poorly controlled or severe cardiovascular disease.
• Subjects with active hepatitis B or active hepatitis C.
• A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
• The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.

Egyéb

• Subjects with known or suspected interstitial pneumonia.
• Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
• Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.

• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• Male or female ≥ 18 years old and ≤75 years old.
• ECOG performance status of 0-1.
• Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks.
• Need to provided tumor tissue samples for genetic testing.