A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

NCT06978114 | Recruiting Phase 2

• 1 other identifier: BL-B01D1-204-10
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Biliary Tract Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

  Up to approximately 24 months

• Recommended Phase II Dose (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.

  Up to approximately 24 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

BL-B01D1+Pembrolizumab

EXPERIMENTAL

Participants receive BL-B01D1+Pembrolizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-B01D1; Drug: Pembrolizumab

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1+Pembrolizumab

Pembrolizumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1+Pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

CN (1)