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;
Parallel
BL-B01D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Docetaxel or Paclitaxel
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Overall survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
