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RecruitingNCT07582315Updated Jul 24, 2026

A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)

A Phase 3 interventional study of BL-B01D1 and Oxaliplatin in Biliary Tract Cancer, sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Sichuan Baili Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
538
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.

Read the detailed description

In this trial, the experimental group receives BL-B01D1 administered once every 3 weeks (Q3W), while the control group receives the investigator's choice of protocol.

02

Conditions studied

  • Biliary Tract Cancer
03

In context

Biliary Tract Neoplasms

484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.

This study's planned enrollment of 538 is above the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.

Browse Biliary Tract Neoplasms studies →

Lead sponsor

Sichuan Baili Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
  2. No gender restriction, aged ≥18 years and ≤75 years;
  3. Expected survival time ≥3 months;
  4. Patients with locally advanced or metastatic biliary tract cancer;
  5. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;
  6. Must have at least one measurable lesion as defined by RECIST v1.1;
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
  9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
  10. Organ function levels must meet the specified requirements;
  11. Urine protein ≤2+ or ≤1000 mg/24h;
  12. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy testing excluding pregnancy, and they must be non-lactating; all enrolled patients (regardless of male or female) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.

Exclusion criteria

Exclusion Criteria:

  1. Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to randomization;
  2. Patients with locally advanced or metastatic biliary tract cancer who are suitable for curative local therapy;
  3. Prior use of ADC drugs using topoisomerase I inhibitors as the toxin, or prior treatment with ADC drugs targeting EGFR and/or HER3;
  4. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
  5. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
  6. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
  7. Diagnosis of active malignancy within 3 years prior to randomization;
  8. Hypertension poorly controlled by two antihypertensive medications, history of hypertensive crisis or hypertensive encephalopathy;
  9. Poorly controlled blood glucose levels;
  10. History of non-infectious interstitial lung disease (ILD) treated with steroids, etc.;
  11. Concurrent pulmonary disease resulting in clinically severe respiratory impairment;
  12. Patients with active central nervous system metastases;
  13. Severe infection occurring within 4 weeks prior to randomization;
  14. Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions;
  15. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, thorax, neck, or pharynx;
  16. Serious non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed consent form;
  17. Clinically significant bleeding or obvious bleeding tendencies in trial participants within 4 weeks prior to signing the informed consent form;
  18. Patients with a history of allergy to recombinant humanized antibodies or to any excipient component of BL-B01D1;
  19. Positive for human immunodeficiency virus antibodies, active tuberculosis, active hepatitis B virus infection, or hepatitis C virus infection;
  20. History of severe neurological or psychiatric disorders;
  21. Trial participants planning to receive or having received a live vaccine within 28 days prior to randomization;
  22. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
538 participants (estimated)

Study arms

  • Experimental
    BL-B01D1

    Participants receive BL-B01D1 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

  • Active comparator
    mFOLFOX, FOLFnal-IRI or XELIRI

    Participants receive mFOLFOX, FOLFnal-IRI or XELIRI in the first cycle (2 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: Oxaliplatin · Drug: Calcium levofolinate · Drug: Fluorouracil · Drug: Irinotecan Hydrochloride Liposome · Drug: Irinotecan Hydrochloride · Drug: Capecitabine

Interventions

  • DrugBL-B01D1

    Administration by intravenous infusion for a cycle of 3 weeks.

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

  • DrugOxaliplatin

    Administration by intravenous infusion for a cycle of 2 weeks.

  • DrugCalcium levofolinate

    Administration by intravenous infusion for a cycle of 2 weeks.

  • DrugFluorouracil

    Administration by intravenous infusion for a cycle of 2 weeks.

  • DrugIrinotecan Hydrochloride Liposome

    Administration by intravenous infusion for a cycle of 2 weeks.

  • DrugIrinotecan Hydrochloride

    Administration by intravenous infusion for a cycle of 2 weeks.

  • DrugCapecitabine

    Oral administration for a cycle of 2 weeks.

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Progression-free survival (PFS)

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

    Time frame: Up to approximately 24 months

  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).

    Time frame: 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.

    Time frame: Up to approximately 24 months

  4. 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.

    Time frame: Up to approximately 24 months

  5. 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.

    Time frame: Up to approximately 24 months

  6. Anti-drug antibody (ADA)

    Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.

    Time frame: Up to approximately 24 months

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing Municipality, China
    • Lin Shen · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07582315
Lead sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Jun 29, 2026
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 24, 2026

Study contacts

Sa Xiao, PHD
Contact
xiaosa@baili-pharm.com
15013238943

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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