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
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator