Phase III Trial Comparing BL-B01D1 to Standard Chemotherapy for Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

What this Trial Is About

Researchers are evaluating the efficacy and safety of BL-B01D1 compared to the investigators choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This phase III, randomized, open-label, multicenter trial focuses on patients who have previously received platinum-based treatments and experienced recurrence or progression. The study aims to better understand treatment options for this challenging condition. Participants are randomly assigned to receive either BL-B01D1, given by intravenous infusion in 3-week cycles, or one of several chemotherapies selected by the investigatorliposomal doxorubicin, paclitaxel, or topotecanadministered via intravenous infusion in 4-week cycles. Those showing clinical benefit may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons lead to stopping treatment. During the trial, participants undergo regular assessments including tumor measurements and safety evaluations up to approximately 24 months. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and treatment-related side effects. Tissue samples are collected for analysis, and patients health and organ functions are closely observed to ensure safety throughout the study duration.

A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)