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

Inclusion Criteria:

1. Voluntary participation and written informed consent；
2. Aged 18-75 years (inclusive), males and females;
3. Consents to provide tumor tissue samples;
4. Subjects must have histologically or clinically confirmed advanced and/or metastaticmalignancies for which failure of standard treatment or lack of effective standardtreatment;
5. At least one measurable lesion according to RECIST v1.1;
6. ECOG score of 0-1;
7. Expected survival ≥ 12 weeks;
8. Adequate bone marrow reserve and organ function ；
9. For female patients of childbearing potential or male patients with partners ofchildbearing potential who are not sterilized by surgical operations, they arerequired to use a medically approved contraceptive measure during the study treatmentperiod and within 3 months after the end of the study treatment; For female patientsof childbearing potential who are not sterilized by surgical operations, they musthave a negative serum HCG test result within 72 h prior to study enrollment; and theymust not be in the lactation period;

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 currentILD/pneumonitis;
8. Has a history of active chronic enteritis 6 weeks prior to the initiation of the studytreatment or intestinal obstruction, gastrointestinal perforation 3 months prior tothe initiation of the study treatment;
9. Has a history of Grade≥2 bleeding 4 weeks prior to the initiation of the studytreatment 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 theinitiation 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 orinactive ingredients of SHR-A1921;
14. Subjects with other potential factors that may affect the study results or result inthe premature discontinuation as determined by the investigator, such as alcoholism,drug abuse, other serious diseases (including mental illness) requiring concomitanttreatment, serious laboratory abnormalities, or family or social factors that couldaffect the safety of the patients.