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 and PD-1/PD-L1 Monoclonal Antibody Therapy(PANKU-BTC01)

May 19, 2026 updated by: Sichuan Baili Pharmaceutical Co., Ltd.

A Phase III Randomized Controlled Clinical 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 and PD-1/PD-L1 Monoclonal Antibody Therapy

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 and PD-1/PD-L1 antibody therapy.

Study Overview

Status

Not yet recruiting

Conditions

Biliary Tract Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

538

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sa Xiao, PHD
Phone Number: 15013238943
Email: xiaosa@baili-pharm.com

Study Locations

China
- Beijing Municipality
  - Beijing, Beijing Municipality, China
    - Beijing Cancer Hospital
    - Contact:
      
      Lin Shen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
No gender restriction, aged ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Patients with locally advanced or metastatic biliary tract cancer;
Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;
Must have at least one measurable lesion as defined by RECIST v1.1;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
Organ function levels must meet the specified requirements;
Urine protein ≤2+ or ≤1000 mg/24h;
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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Administration by intravenous infusion for a cycle of 3 weeks. Other Names: BMS-986507 iza-bren izalontamab brengitecan
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: Capecitabine Oral administration for a cycle of 2 weeks. Drug: Oxaliplatin Administration by intravenous infusion for a cycle of 2 weeks. Drug: Calcium levofolinate Administration by intravenous infusion for a cycle of 2 weeks. Drug: Fluorouracil Administration by intravenous infusion for a cycle of 2 weeks. Drug: Irinotecan Hydrochloride Liposome Administration by intravenous infusion for a cycle of 2 weeks. Drug: Irinotecan Hydrochloride Administration by intravenous infusion for a cycle of 2 weeks.

Participant Group / Arm

Intervention / Treatment

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

Administration by intravenous infusion for a cycle of 3 weeks.

Other Names:

BMS-986507
iza-bren
izalontamab brengitecan

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: Capecitabine

Oral administration for a cycle of 2 weeks.

Drug: Oxaliplatin