This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Age: ≥18 years old;
Expected survival time ≥3 months;
Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
Use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives prior to study randomization and palliative radiotherapy, etc., within 2 weeks;
Patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy;
Front line received ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3;
History of severe heart disease and cerebrovascular disease;
Parallel
BL-B01D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Liposomal doxorubicin, Paclitaxel or Topotecan
DrugAdministration by intravenous infusion for a cycle of 4 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.
Time to Response (TTR)
Time to Response (TTR) is defined per RECIST v1.1 criteria as the time from the date of randomization to the date of first documented objective response (either Complete Response \[CR\] or Partial Response \[PR\]), whichever occurs first.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
