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)

Официальное название

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(PANKU-BTC01)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Oxaliplatin
  Administration by intravenous infusion for a cycle of 2 weeks.
• Препарат Calcium levofolinate
  Administration by intravenous infusion for a cycle of 2 weeks.
• Препарат Fluorouracil
  Administration by intravenous infusion for a cycle of 2 weeks.
• Препарат Irinotecan Hydrochloride Liposome
  Administration by intravenous infusion for a cycle of 2 weeks.
• Препарат Irinotecan Hydrochloride
  Administration by intravenous infusion for a cycle of 2 weeks.
• Препарат Capecitabine
  Oral administration for a cycle of 2 weeks.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (6)

• Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Anti-drug antibody (ADA) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07582315 · BL-B01D1-317

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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