Status:
RECRUITING
A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- Age: ≥18 years old;
- Expected survival time ≥3 months;
- Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
- Previously treated with a platinum-based regimen and confirmed to have platinum-resistant recurrence;
- Previously received 1-3 lines of systemic anti-tumor therapy, with radiographic evidence of disease progression during or after the last line of treatment or intolerance to the current treatment prior to randomization;
- For subjects with documented folate receptor-alpha (FRα) positivity, progression must have occurred after treatment with mirvetuximab soravtansine;
- Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 3 years;
- Must have at least one measurable lesion as defined by RECIST v1.1;
- ECOG performance status score of 0 or 1;
- Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
- Organ function levels must meet the requirements;
- Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients should use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.
Exclusion
- 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;
- Patients with locally advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer who are eligible for radical locoregional therapy;
- Front line received ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3;
- History of severe heart disease and cerebrovascular disease;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Diagnosed with active malignancy within 3 years before randomization;
- Hypertension poorly controlled by two antihypertensive drugs;
- Patients with poor glycemic control;
- Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD;
- Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- Patients with active central nervous system metastases;
- Severe infection occurred within 4 weeks before randomization in study 13; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
- Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;
- Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- Patients with inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;
- Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
- Had a history of autologous or allogeneic stem cell transplantation;
- Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
- A history of severe neurological or psychiatric illness;
- Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;
- Subjects who were scheduled to be vaccinated or received live vaccine within 28 days before study randomization;
- Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT06994195
Start Date
August 4 2025
End Date
December 1 2027
Last Update
August 17 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China