Phase III Study Comparing BL-B01D1 to Physicians Choice Treatment in Adults 18-75 with Advanced or Metastatic Biliary Tract Cancer After Platinum Chemotherapy Failure

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a drug called BL-B01D1 compared with a physicians choice of treatment in adults aged 18 to 75 years with locally advanced or metastatic biliary tract cancer who have not responded to prior platinum-based chemotherapy. This Phase III, randomized, open-label, multicenter study aims to provide new treatment options for this condition after standard therapy has failed. Participants in the experimental group receive BL-B01D1 via intravenous infusion once every three weeks. The control group receives one of several chemotherapy regimensmFOLFOX, FOLFnal-IRI, or XELIRIadministered in cycles of two weeks. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. Those who benefit clinically from their assigned treatment may continue receiving additional cycles. During the study, participants undergo regular assessments including tumor measurements, safety evaluations, and antibody testing up to about 24 months. Researchers measure overall survival as the primary outcome and monitor progression-free survival, response rates, duration of response, disease control, and treatment-related adverse events as secondary outcomes. The trial lasts until December 2028, with ongoing monitoring to evaluate treatment effects and safety.

A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)