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;
Chemotherapy, targeted therapy, biological therapy, etc. were used within 4 weeks or 5 half-lives before randomization;
Patients with locally advanced or metastatic urothelial carcinoma who were suitable for radical local therapy were excluded;
Frontline received ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3; The front line had received both paclitaxel and docetaxel;
History of severe heart disease and cerebrovascular disease;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator