Phase III Study Comparing BL-M07D1 to Doctors Choice Chemotherapy for HER2-Positive Advanced or Metastatic Biliary Tract Cancer After Platinum Treatment

What this Trial Is About

Researchers are evaluating BL-M07D1 compared to the physicians choice of chemotherapy in patients with HER2-expressing locally advanced or metastatic biliary tract cancer who have experienced failure after platinum-containing chemotherapy. This Phase III, randomized, open-label, multicenter study aims to assess the efficacy and safety of BL-M07D1 in this patient group, addressing an important treatment need after prior therapy has not succeeded. Participants are assigned to one of two groups. The treatment group receives BL-M07D1 administered by intravenous infusion in 3-week cycles. Participants showing clinical benefit may continue treatment for additional cycles, with therapy ending due to disease progression, intolerable side effects, or other reasons. The control group receives chemotherapy chosen by their physician, including mFOLFOX, FOLFnal-IRI, or XELIRI regimens, given by intravenous infusion or oral administration in 2-week cycles, with similar continuation and stopping rules. During the study, participants undergo regular assessments to monitor overall survival, progression-free survival, tumor response rates, duration of response, and treatment-emergent adverse events for up to approximately 24 months. Safety is closely observed, including monitoring for anti-drug antibodies. The study includes patients aged 18 to 75 years with confirmed biliary tract cancer and good performance status. The total study timeline extends up to two years, allowing researchers to evaluate long-term outcomes and treatment effects.

A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure