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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Voluntarily sign the informed consent form and comply with the protocol requirements;

Be ≥18 years and ≤75 years old on the day of signing the informed consent form;

Have an expected survival time of ≥3 months;

Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;

Disqualifiers

Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;

Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;

History of severe cardiovascular or cerebrovascular disease within six months before screening;

Concurrent pulmonary disease resulting in severely impaired lung function;

Trial design

Treatments tested in this trial

  • BL-M07D1
  • Liposomal Doxorubicin
  • Paclitaxel
  • Topotecan

Treatment groups

404 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator