Phase III Study Comparing BL-B01D1 Infusion to Chemotherapy in Adults With Recurrent or Metastatic Urothelial Carcinoma After PD-1PD-L1 and Platinum Treatment

What this Trial Is About

Researchers are evaluating the efficacy and safety of BL-B01D1 in people with recurrent or metastatic urothelial carcinoma who have not responded to prior PD-1PD-L1 monoclonal antibody and platinum-based chemotherapy. This phase III, randomized, open-label, multicenter study compares BL-B01D1 with chemotherapy selected by the physician. The goal is to better understand treatment outcomes for patients facing this advanced bladder cancer after other therapies have failed. Participants receive either BL-B01D1 or one of two chemotherapy drugs, Docetaxel or Paclitaxel, administered by intravenous infusion every 3 weeks. Those who benefit from the initial cycle may continue treatment for additional cycles unless disease progression, unacceptable side effects, or other reasons require stopping. Both treatment options follow the same cycle length and administration method. During the study, participants will be monitored for up to about 24 months to assess progression-free survival and overall survival as the main outcomes. Secondary assessments include response rates, disease control, duration of response, treatment side effects, and immune reaction against the drug. Researchers will also evaluate tumor samples and health status through regular visits and tests throughout the study period. Safety and treatment effects will be carefully tracked during and after treatment.

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)