a study comparing bl-b01d1 with the investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Summary: this trial is a registered, phase iii, randomized, open-label, multicenter study to evaluate the efficacy and safety of bl-b01d1 in patients with platinum-resistant recurrent epithelial ovarian cancer.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. age: ≥18 years old; 3. expected survival time ≥3 months; 4. epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer confirmed by histopathology or cytology; 5. patients who had been treated with platinum-based regimens and had proven platinum-resistant relapse; 6. patients with platinum-6 resistance had received at most one line of systemic anti-tumor therapy, and were suitable for single-agent chemotherapy in the next line of therapy; 7. agree to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years; 8. at least one measurable lesion meeting the recist v1.1 definition was required; 9. ecog 0 or 1; 10. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by nci-ctcae v5.0; 11. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 12. organ function level must meet the requirements; 13. a serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal women of childbearing potential, and the result must be negative and must not be lactating; all enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. exclusion criteria: 1. use of chemotherapy, targeted therapy, biologic therapy, etc., within 4 weeks or 5 half-lives prior to study randomization and palliative radiotherapy, etc., within 2 weeks; 2. patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy; 3. front line received adcs targeting topoisomerase i inhibitors or egfr and/or her3; 4. history of severe heart disease and cerebrovascular disease; 5. unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 6. prolonged qt interval, complete left bundle branch block, iii degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. diagnosed with active malignancy within 3 years before randomization; 8. hypertension poorly controlled by two antihypertensive drugs; 9. patients with poor glycemic control; 10. patients with grade ≥1 radiation pneumonitis according to the rtog/eortc definition; previous history of ild; 11. complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 12. patients with active central nervous system metastases; 13. severe infection occurred within 4 weeks before randomization in study 13; evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization; 14. patients with massive or symptomatic effusions or poorly controlled effusions; 15. imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx; 16. serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent; 17. subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 18. patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea; 19. patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of bl-b01d1; 20. had a history of autologous or allogeneic stem cell transplantation; 21. human immunodeficiency virus antibody positive, active hepatitis b virus infection or hepatitis c virus infection; 22. a history of severe neurological or psychiatric illness; 23. received other unmarketed investigational drugs or treatments within 4 weeks before randomization; 24. subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization; 25. other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.