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

StatusRecruiting
PhasePhase 3
Started2025-08-04
View on ClinicalTrials.gov ↗

Amendment history

2026-07-03
notable
Study Status, Study Design, Outcome Measures v4
Enrollment increased: 384 → 450 participants
Secondary endpoints7 to 8 entries
Time to Response (TTR)
2026-04-15
minor
Study Identification, Study Status v3
Study title+13 characters
[...] With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)
2025-08-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08→confirmed 2025-08-04
Study sitesdetails revised at 1 of 1 site
2025-07-31
minor
Study Status, Study Design, Outcome Measures, Eligibility v1
Start date2025-05→2025-08
Enrollment target540→384
Eligibility criteria+353 characters
Inclusion Criteria: SignVoluntarily sign the informed consent form voluntarily and followcomply with the protocol requirements; Age: ≥18 years old; Expected survival time ≥3 months; EpithelialHistologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, andor primary peritoneal cancer confirmed by histopathology or cytology; Patients who had beenPreviously treated with a platinum-based regimensregimen and hadconfirmed provento have platinum-resistant relapserecurrence; Patients with platinum-6 resistance hadPreviously received at1-3 most one linelines of systemic [...] [...]
Secondary endpoints8 to 7 entries
Overall survival (OS)
Primary endpoints1 to 2 entries
Overall survival (OS)
2025-05-20
minor
Original filing
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.
Trial Details
NCT Number NCT06994195
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Enrollment 450 participants
Start Date 2025-08-04
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-07