BL-B01D1 vs physician’s choice in biliary tract cancer after platinum failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label phase 3 study evaluating the efficacy and safety of BL-B01D1 given every 3 weeks versus the investigator's choice chemotherapy in adults with locally advanced or metastatic biliary tract cancer after platinum-based therapy failure. Eligible participants will have measurable disease, good performance status, and adequate organ function, and will provide tumor tissue samples for biomarker analysis. Primary and secondary endpoints typically include objective response rate, progression-free survival, overall survival, and safety. The trial is sponsored by Sichuan Baili Pharmaceutical with Baili-Bio as collaborators and is conducted at participating centers in China.

Why it matters

Who can join: the full rules

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:

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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.