Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic 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;
• Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
• 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 ;
• If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be < 500 IU / mL；
• 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;
• 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;