Actively Recruiting
A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-07-02
46
Participants Needed
1
Research Sites
129 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
This study is a clinical study to explore the efficacy and safety of BL-B01D1+PD-1/PD-L1 monoclonal antibody in patients with advanced biliary tract cancer.
CONDITIONS
Official Title
A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to follow protocol requirements
- Any gender
- Age between 18 and 75 years old
- Expected survival time of at least 3 months
- Confirmed diagnosis of advanced biliary tract cancer by histology or cytology
- Provided tumor tissue sample within the past 3 years for PD-L1 and other testing
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Toxicity from prior cancer treatments resolved to grade 1 or less per NCI-CTCAE v5.0
- No severe cardiac dysfunction with left ventricular ejection fraction of 50% or higher
- Adequate organ function as required
- Coagulation function with INR and APTT less than or equal to 1.5 times the upper limit of normal
- Urinary protein less than or equal to 2+ or 1000 mg per 24 hours
- Negative pregnancy test for premenopausal women of childbearing potential within 7 days before treatment
- Use of effective contraception during treatment and for 6 months after treatment end
You will not qualify if you...
- Active metastases in the central nervous system
- Participation in another clinical trial within 4 weeks before this study dose
- Cancer treatment such as chemotherapy, radiotherapy, or biological therapy within 4 weeks before first study dose
- Major surgery within 4 weeks before first study dose
- History of severe immune-related adverse events or myocarditis from prior immunotherapy
- Use of immunomodulatory drugs within 14 days before first study dose
- Requirement for systemic corticosteroids or immunosuppressants within 2 weeks before study start
- Pulmonary disease grade 3 or higher or history of interstitial lung disease requiring steroids
- Severe systemic infections within 4 weeks before screening
- Active or history of autoimmune disease
- Other cancers within 5 years before first study dose
- Positive for HIV, active tuberculosis, hepatitis B or C infections
- Poorly controlled hypertension despite two antihypertensive medications
- Diabetes with poor blood sugar control
- History of severe heart or brain blood vessel diseases
- Previous stem cell, bone marrow, or organ transplant
- Recent significant bleeding or bleeding tendency within 4 weeks
- Presence of large or symptomatic fluid collections not well controlled
- Tumor invading or surrounding major arteries or heart structures
- Unstable clotting events needing treatment within 6 months
- Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors
- Allergy to recombinant humanized antibodies or trial drug components
- Prior cumulative anthracycline dose over 360 mg/m2
- Pregnant or breastfeeding women
- History of psychotropic drug abuse or untreated mental disorders
- Any other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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