A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

Официальное название

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

Обзор

This study is a clinical study to explore the efficacy and safety of BL-B01D1+PD-1/PD-L1 monoclonal antibody in patients with advanced biliary tract cancer.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Pembrolizumab
  Administration by intravenous infusion for a cycle of 3 weeks.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Recommended Phase II Dose (RP2D) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Patients with advanced biliary tract cancer confirmed by histology or cytology;
• Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG score 0-1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• Organ function level must meet the requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Urinary protein ≤2+ or ≤1000mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Критерии исключения

• Patients with active central nervous system metastases;
• Who had participated in any other clinical trial within 4 weeks before the trial dose;
• Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;
• Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;
• Had received immunotherapy and developed grade ≥3 irAE or grade ≥2 immune-related myocarditis;
• Use of immunomodulatory drugs within 14 days before the first dose of study drug;
• Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before the study administration;
• Pulmonary disease grade ≥3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment;
• Severe systemic infection occurred within 4 weeks before screening;
• Patients at risk for active autoimmune disease or with a history of autoimmune disease;
• Other malignant tumors within 5 years before the first dose;
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
• Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;
• Diabetic patients with poor glycemic control;
• Had a history of severe cardiovascular and cerebrovascular diseases;
• Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;
• Subjects with clinically significant bleeding or significant bleeding tendency within the preceding 4 weeks were screened;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
• Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of the trial drug;
• The cumulative dose of anthracyclines > 360 mg/m2 in previous (new) adjuvant therapy;
• Pregnant or lactating women;
• Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
• The investigator did not consider it appropriate to apply other criteria for participation in the trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital Fudan University — Шанхай

Идентификаторы

NCT: NCT06978114 · BL-B01D1-204-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗