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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07545460
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-M07D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Liposomal Doxorubicin — DRUG
    Administration by intravenous infusion for a cycle of 4 weeks.
  • Paclitaxel — DRUG
    Administration by intravenous infusion for a cycle of 4 weeks.
  • Topotecan — DRUG
    Administration by intravenous infusion for a cycle of 4 weeks.

Study Details

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.

Key Dates

First listed
Apr 22, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
404 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-M07D1
    Participants receive BL-M07D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
  • Active Comparator: physician's choice of chemotherapy
    Participants receive liposomal doxorubicin, paclitaxel or topotecan in the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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