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)

NCT07582315 | Not Yet Recruiting Phase 3

• 1 other identifier: BL-B01D1-317
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief 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 and PD-1/PD-L1 antibody therapy.

Conditions

Biliary Tract Cancer

Outcome Measures

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.

  Up to approximately 24 months

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (2)

BL-B01D1

EXPERIMENTAL

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

mFOLFOX, FOLFnal-IRI or XELIRI

ACTIVE COMPARATOR

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

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

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

BL-B01D1

Oxaliplatin DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Fluorouracil DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Irinotecan Hydrochloride Liposome DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Irinotecan Hydrochloride DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Calcium levofolinate DRUG

Administration by intravenous infusion for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Capecitabine DRUG

Oral administration for a cycle of 2 weeks.

mFOLFOX, FOLFnal-IRI or XELIRI

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Oxaliplatin; Fluorouracil; Irinotecan; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)