Status:
RECRUITING
A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions:
Advanced Biliary Tract Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age ≥18 years old and ≤75 years old;
- Expected survival time ≥3 months;
- Patients with advanced biliary tract cancer confirmed by histology or cytology;
- Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;
- At least one measurable lesion meeting the RECIST v1.1 definition was required;
- ECOG score 0-1;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- Organ function level must meet the requirements;
- Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Urinary protein ≤2+ or ≤1000mg/24h;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient 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
- Patients with active central nervous system metastases;
- Who had participated in any other clinical trial within 4 weeks before the trial dose;
- Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;
- Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;
- Had received immunotherapy and developed grade ≥3 irAE or grade ≥2 immune-related myocarditis;
- Use of immunomodulatory drugs within 14 days before the first dose of study drug;
- Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before the study administration;
- Pulmonary disease grade ≥3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment;
- Severe systemic infection occurred within 4 weeks before screening;
- Patients at risk for active autoimmune disease or with a history of autoimmune disease;
- Other malignant tumors within 5 years before the first dose;
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
- Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;
- Diabetic patients with poor glycemic control;
- Had a history of severe cardiovascular and cerebrovascular diseases;
- Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;
- Subjects with clinically significant bleeding or significant bleeding tendency within the preceding 4 weeks were screened;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
- Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of the trial drug;
- The cumulative dose of anthracyclines \> 360 mg/m2 in previous (new) adjuvant therapy;
- Pregnant or lactating women;
- Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
- The investigator did not consider it appropriate to apply other criteria for participation in the trial.
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06978114
Start Date
June 10 2025
End Date
December 1 2027
Last Update
July 2 2025
Active Locations (1)
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1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China