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Advanced Biliary Tract CancerPhase 2NCT06978114

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

A Phase 2 study testing BL-B01D1 and Pembrolizumab in people with Advanced Biliary Tract Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Biliary Tract Cancer
What is being tested?
BL-B01D1 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
10 Jun 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality

    Jian Zhou

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
BL-B01D1, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-B01D1Drug

    Also called iza-bren, izalontamab brengitecan, BMS-986507

    Administration by intravenous infusion for a cycle of 3 weeks.

  • PembrolizumabDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06978114
Study groupRoleWhat they receive
BL-B01D1+PembrolizumabExperimentalParticipants 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.
Receives: Drug: BL-B01D1; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to approximately 24 months

  2. 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.

    Measured: Up to approximately 24 months

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

    Measured: Up to approximately 24 months

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Measured: Up to approximately 24 months

  3. Duration of Response (DOR)

    Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Measured: Up to approximately 24 months

  4. Treatment Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start10 Jun 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06978114
Sponsor's protocol ID
BL-B01D1-204-10
Status last verified
Jul 2025
First submitted
11 May 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BL-B01D1 and Pembrolizumab in people with Advanced Biliary Tract Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06978114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.

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