A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors

Inclusion criteria

• Voluntary participation and written informed consent.
• 18-75 years older, no gender limitation.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• With a life expectancy ≥ 3 months.
• Pathologically diagnosed advanced solid tumor.
• Be able to provide fresh or archived tumour tissue.
• At least one measurable lesion according to RECIST v1.1.
• Adequate bone marrow reserve and organ function.
• Contraception is required during the trial.

Exclusion criteria

• Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
• Uncontrollable tumor-related pain.
• Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
• Received systemic antitumor therapy before the first dose.
• Treated with similar target therapy as SHR-3821 before the first dose.
• Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
• Unresolved CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy.
• Current or History of ILD.
• Active severe digestive disease.
• Previous or co-existing malignancies.
• History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821.
• Active hepatitis B or active hepatitis C.
• Other inappropriate situation considered by the investigator.