This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.
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;
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;
Parallel
SHR-A1904 for Injection
DrugSHR-A1904 for injection, different doses.
Objective response rate (ORR) assessed by investigator.
Phase IIa.
Disease control rate (DCR) assessed by investigator.
Phase IIa/IIb.
Duration of objective tumor response (DoR) assessed by investigator.
Phase IIa/IIb.
Time to response (TTR) assessed by investigator.
Phase IIa/IIb.
Progression-free survival (PFS) assessed by investigator.
Phase IIa/IIb.
Click on the lead sponsor to view all of their trials.
