A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer

Inclusion criteria

• Age 18-75 years old (including both ends), male or female;
• ECOG-PS score: 0 or 1;
• Expected survival ≥ 12 weeks;
• Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
• CLDN18.2 positive expression;
• Subjects who failed or intolerance after systemic chemotherapies;
• According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
• The main organ function is normal, in line with the program requirements;
• Consent to contraception.

Exclusion criteria

• Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
• Other active malignancies within 5 years or at the same time;
• Subjects with a history or evidence of brain metastasis or meningeal metastasis;
• With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C;
• Severe trauma or major surgery was performed within 4 weeks before the first administration;
• To study the severe heart disease within 6 months before the first administration;
• Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;
• Severe infection symptoms occurred within 2 weeks before the first administration;
• Known hereditary or acquired bleeding and thrombotic tendency;
• Congenital or acquired immune defects;
• The subjects had severe and uncontrollable concomitant diseases;
• Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.