A Phase III Randomized Controlled Clinical 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
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;
• Have locally advanced or metastatic biliary tract cancer;
• Have a known genetic mutation;
• Be suitable to receive the control arm regimen;
• Have at least one measurable lesion as defined by RECIST v1.1;
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
⁃ Have recovered from previous anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
⁃ Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;
⁃ Meet the required organ function levels;
⁃ For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative for pregnancy; they must be non-lactating. All enrolled trial participants should practice adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.