Clinical trial NCT06994195: A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer
Official title: A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
First posted: 2025-05-29
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 24 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 24 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 24 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 24 months
measure: RR (Response Rate)
timeFrame: Up to approximately 24 months
measure: CA-125 Response Rate
timeFrame: Up to approximately 24 months
measure: Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 24 months
measure: Anti-drug antibody (ADA)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: