A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressi… (NCT07545460) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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
China404 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Have previously received a platinum-based regimen and have been confirmed to have platinum-resistant recurrence;
✓. Have received a total of ≥1 and ≤3 prior lines of therapy;
✓. If previously confirmed to be folate receptor alpha (FRα)-positive, must have received treatment with mirvetuximab soravtansine;
✓. Agree to provide archived tumor tissue specimens (from primary or metastatic lesions) collected within 3 years, or fresh tissue samples;
Exclusion criteria
✕. 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;