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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 538
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Irinotecan Hydrochloride (Drug)
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.
干预措施: Calcium levofolinate (Drug)
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.
干预措施: Fluorouracil (Drug)
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.
干预措施: Oxaliplatin (Drug)
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.
干预措施: Irinotecan Hydrochloride Liposome (Drug)
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.
干预措施: Capecitabine (Drug)
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.
干预措施: BL-B01D1 (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 24 months
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
次要结局
- 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)
- Anti-drug antibody (ADA)(Up to approximately 24 months)