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A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

StatusNot Yet Recruiting
PhasePhase 3
Started2026-07
View on ClinicalTrials.gov ↗

Amendment history

2026-06-26
minor
Study Status, Eligibility, Contacts/Locations v1
Start date2026-04→2026-07
Study sites1→2
Eligibility criteria-217 characters
[...] tients with active central nervous system (CNS) metastases; Seizure-free status lasting >12 weeks with or without the use of antiepileptic drugs; No requirement for corticosteroid use to control cerebral edema; Radiographically stable status confirmed by two consecutive MRIs; Patients with a history of allergy to recombinant humanized [...]
2026-04-16
minor
Original filing
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
Trial Details
NCT Number NCT07545460
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 404 participants
Start Date 2026-07
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-29