Actively Recruiting
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
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-04-20
384
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This phase III, randomized, open-label, multicenter study compares BL-B01D1 to the investigator's choice of chemotherapy to better understand treatment options for this resistant cancer type. Participants are randomly assigned to receive either BL-B01D1 through intravenous infusion every 3 weeks or one of the chemotherapy options—liposomal doxorubicin, paclitaxel, or topotecan—administered intravenously every 4 weeks. Treatment continues as long as there is clinical benefit or until disease progression, intolerable side effects, or other reasons require stopping. Throughout the study, participants undergo regular assessments to monitor progression-free survival and overall survival for up to about 24 months. Researchers will also evaluate response rates, disease control, duration of response, adverse events, and immune responses. Safety and effectiveness data are collected through clinical exams, imaging, and laboratory tests to track disease status and treatment impact over time.
CONDITIONS
Brief Title
A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and follow protocol requirements
- Age 18 years or older
- Expected survival time of 3 months or more
- Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Previously treated with platinum-based chemotherapy and confirmed platinum-resistant recurrence
- Previously received 1 to 3 lines of systemic anti-tumor therapy with evidence of disease progression or intolerance
- For folate receptor-alpha positive patients, progression after mirvetuximab soravtansine treatment
- Agree to provide tumor tissue samples from the past 3 years
- Have at least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 or 1
- Toxicity from prior therapy recovered to Grade 1 or less per NCI-CTCAE v5.0
- No severe cardiac dysfunction with left ventricular ejection fraction 50% or higher
- Meet required organ function levels
- Coagulation function with INR 1.5 or less and APTT 1.5 times upper limit of normal or less
- Negative pregnancy test within 7 days before treatment and not breastfeeding for premenopausal women; use effective contraception during and 6 months after treatment
You will not qualify if you...
- Use of chemotherapy, targeted or biologic therapy within 4 weeks or 5 half-lives before randomization; palliative radiotherapy within 2 weeks
- Eligible for radical locoregional therapy for platinum-resistant recurrent disease
- Prior frontline treatment with ADCs targeting topoisomerase I inhibitors or EGFR and/or HER3
- History of severe heart or cerebrovascular disease
- Unstable thrombotic events needing treatment within 6 months
- Prolonged QT interval, severe arrhythmias or heart block
- Active malignancy within 3 years before randomization
- Poorly controlled hypertension despite two antihypertensive drugs
- Poor glycemic control
- Grade 1 or higher radiation pneumonitis or prior interstitial lung disease
- Severe respiratory impairment from lung diseases
- Active central nervous system metastases
- Recent severe infection or active pulmonary infection/inflammation
- Large or symptomatic effusions not well controlled
- Tumor invasion or encasement of large blood vessels
- Unhealed serious wounds, ulcers, or fractures within 4 weeks
- Significant bleeding or bleeding tendency within 4 weeks
- Inflammatory bowel disease or severe intestinal conditions
- Allergy to humanized antibodies or BL-B01D1 excipients
- History of stem cell transplantation
- Positive for HIV, active hepatitis B or C infection
- Severe neurological or psychiatric illness
- Use of unmarketed investigational drugs within 4 weeks
- Planned or recent live vaccination within 28 days
- Other conditions deemed inappropriate by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple cycles of 3 to 4 weeks each until disease progression or discontinuation
Participants receive either BL-B01D1 or investigator's choice of chemotherapy by intravenous infusion in repeated cycles. Treatment continues until disease progression, intolerable toxicity, or other reasons for stopping.
1 visit per treatment cycle
Duration - Up to approximately 24 months
Participants are monitored for survival and disease status after treatment ends.
Periodic visits as scheduled by the study
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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