BL-B01D1 plus a PD-1/PD-L1 antibody for advanced biliary tract cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

The treatment combines BL-B01D1 with a PD-1/PD-L1 antibody to see if it helps people with advanced biliary tract cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06978114 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study gives BL-B01D1 together with a PD-1/PD-L1 antibody (pembrolizumab) to adults with histologically confirmed advanced biliary tract cancer. Patients must have at least one measurable lesion per RECIST v1.1, ECOG 0-1, adequate organ and coagulation function, and provide a tumor specimen for PD-L1 testing. The trial monitors safety and anti-tumor activity, allowing prior therapies provided related toxicities have resolved to grade 1 or lower. Enrollment and treatment are conducted at Zhongshan Hospital Fudan University in Shanghai under sponsorship from Sichuan Baili Pharmaceutical and collaborators.

Who should consider this trial

Good fit: Adults age 18–75 with histologically confirmed advanced biliary tract cancer, ECOG 0–1, at least one measurable lesion, adequate organ and coagulation function, and a recent tumor specimen available for PD-L1 testing.

Not a fit: People with poor performance status, expected survival under three months, unresolved high-grade toxicity from prior therapy, significant cardiac dysfunction, or inadequate organ/coagulation function are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the combination could improve response rates or extend survival for people with advanced biliary tract cancer who have limited treatment options.

How similar studies have performed: PD-1/PD-L1 inhibitors have shown modest activity in biliary tract cancers and combination approaches have produced promising signals in some trials but are not yet proven to be broadly effective.

Eligibility criteria

Inclusion Criteria:

1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age ≥18 years old and ≤75 years old;
4. Expected survival time ≥3 months;
5. Patients with advanced biliary tract cancer confirmed by histology or cytology;
6. Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. ECOG score 0-1;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Organ function level must meet the requirements;
12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. 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 Criteria:

1. Patients with active central nervous system metastases;
2. Who had participated in any other clinical trial within 4 weeks before the trial dose;
3. Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;
4. Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;
5. Had received immunotherapy and developed grade ≥3 irAE or grade ≥2 immune-related myocarditis;
6. Use of immunomodulatory drugs within 14 days before the first dose of study drug;
7. Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before the study administration;
8. Pulmonary disease grade ≥3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment;
9. Severe systemic infection occurred within 4 weeks before screening;
10. Patients at risk for active autoimmune disease or with a history of autoimmune disease;
11. Other malignant tumors within 5 years before the first dose;
12. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
13. Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;
14. Diabetic patients with poor glycemic control;
15. Had a history of severe cardiovascular and cerebrovascular diseases;
16. Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;
17. Subjects with clinically significant bleeding or significant bleeding tendency within the preceding 4 weeks were screened;
18. Patients with massive or symptomatic effusions or poorly controlled effusions;
19. 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;
20. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
21. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
22. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of the trial drug;
23. The cumulative dose of anthracyclines \> 360 mg/m2 in previous (new) adjuvant therapy;
24. Pregnant or lactating women;
25. Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
26. The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions: Advanced Biliary Tract Cancer