A Study of SHR-A1921 for Injection in Subjects With Advanced Solid Tumours

Exclusion Criteria

• •1. Known and untreated central nervous system (CNS) or leptomeningeal metastases;
• •2. Macrovascular invasion based on imaging;
• •3. Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
• •4. Has a history of a second malignancy;
• •5. History of immunodeficiency disease or organ transplant;
• •6. Uncontrolled cardiac diseases or symptoms;
• •7. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
• •8. Has a history of active chronic enteritis 6 weeks prior to the initiation of the study treatment or intestinal obstruction, gastrointestinal perforation 3 months prior to the initiation of the study treatment;
• •9. Has a history of Grade≥2 bleeding 4 weeks prior to the initiation of the study treatment or is current receiving anticoagulation therapy;
• •10. Subjects with active hepatitis B or active hepatitis C;
• •11. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
• •12. Has unresolved toxicities from previous anticancer therapy.
• •13. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921;
• •14. Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.