A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platin… (NCT06994195) | Clinical Trial Compass
RecruitingPhase 3
A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)
China384 participantsStarted 2025-08-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence;
✓. Previously received 1-3 lines of systemic anti-tumor therapy, with radiographic evidence of disease progression during or after the last line of treatment or intolerance to the current treatment prior to randomization;
✓. For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine;
✓. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years;
Exclusion criteria
✕. 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;