A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer

Launched by SICHUAN BAILI PHARMACEUTICAL CO., LTD. · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BL-B01D1 for patients with certain types of recurrent ovarian cancer that do not respond to platinum-based chemotherapy. The trial aims to see how well BL-B01D1 works compared to other chemotherapy options that doctors might choose. It's a phase III study, which means it’s in the later stages of testing, and it will involve patients from multiple locations. If you are an adult aged 18 or older with specific types of ovarian, fallopian tube, or peritoneal cancer that has returned after treatment with platinum-based drugs, you might be eligible to participate.

Participants in this trial will receive either BL-B01D1 or the chemotherapy chosen by their doctor, and they can expect to be closely monitored for side effects and how well the treatment is working. It’s important for potential participants to meet specific health criteria, such as having measurable cancer lesions and having recovered from any previous treatments. Additionally, women of childbearing age will need to take precautions to avoid pregnancy during the study. This trial is not yet recruiting, so interested individuals should check back for updates on when it starts.

Gender

ALL

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.