This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after platinum-containing chemotherapy failure.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Be ≥18 years and ≤75 years old on the day the trial participant signs the informed consent form;
Have an expected survival time of ≥3 months;
Have a histologically or cytologically confirmed pathological diagnosis of biliary tract cancer;
Received surgical treatment, radical radiotherapy, chemotherapy, etc., within 4 weeks prior to the first dose;
Patients with locally advanced or metastatic biliary tract cancer who are suitable for receiving curative-intent local therapy;
Previously treated with ADC drugs using camptothecin derivatives as the toxin;
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