A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma After Failure of PD-1/PD-L1 Monoclonal Antibody and Platinum-based Chemotherapy
This trial is a registered phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic urothelial carcinoma after failure of PD-1/PD-L1 monoclonal antibody and platinum-based chemotherapy.
• Sign the informed consent form voluntarily and follow the protocol requirements;
• Age: ≥18 years old;
• Expected survival time ≥3 months;
• Patients with unresectable locally advanced or metastatic urothelial carcinoma who had failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors;
• Patients with locally advanced or metastatic urothelial carcinoma who are eligible for treatment with the control chemotherapy agents specified in this protocol;
• Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
⁃ No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
⁃ If blood transfusion and colony-stimulating factor were not allowed within 14 days before randomization, the organ function level had to meet the requirements;
⁃ A serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal women of childbearing potential, and the result must be negative and must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.