A Study of SHR-9803 for Injection in Patients With Advanced Solid Tumors

Inclusion criteria

• Voluntary participation and written informed consent.
• 18-75 years old, no gender limitation.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1
• With a life expectancy ≥ 3 months.
• Pathologically diagnosed advanced solid tumor.
• At least one measurable lesion according to RECIST v1.1.
• Adequate bone marrow reserve and organ function.
• Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion criteria

• Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
• Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
• Previous or co-existing malignancies；
• Severe bone damage caused by bone metastasis， including uncontrolled tumor-related pain;
• Have active or prior documented autoimmune disease;
• Have used corticosteroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 2 weeks;
• With poorly controlled or severe cardiovascular disease;
• A history of interstitial pneumonia/non-infectious pneumonia;
• Severe infection 1 month before the first dose;
• Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
• With a history of inflammatory bowel disease, or those who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to the first dose;
• Have received more than 30 Gy of pulmonary radiation therapy within 6 months prior to the first dose; Have received major surgery，Systemic chemotherapy, endocrine therapy, monoclonal antibody therapy, macromolecular targeted therapy or other investigational products within 4 weeks; or palliative radiotherapy within 2 weeks; or oral small-molecule targeted drugs within five half-lives;
• Have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1;
• Received live-attenuated vaccines within 4 weeks prior to the first dose.
• Known to have had an allergic reaction to other monoclonal antibodies.