This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.
Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
No gender restriction, aged ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Patients with locally advanced or metastatic biliary tract cancer;
Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to randomization;
Patients with locally advanced or metastatic biliary tract cancer who are suitable for curative local therapy;
Prior use of ADC drugs using topoisomerase I inhibitors as the toxin, or prior treatment with ADC drugs targeting EGFR and/or HER3;
History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator