A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Официальное название

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Обзор

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат PD-1 Monoclonal Antibody
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Pemetrexed Disodium
  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;
• Any gender;
• Age: ≥18 years old;
• Expected survival time for 3 months or more;
• Patients with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology;
• Subjects were able to provide 6-10 slides of archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No serious cardiac dysfunction, left ventricular ejection fraction 50% or higher;
• screening period not allowed within 14 days before a blood transfusion, are not allowed to use any cell growth factor, and/or liters of platelet medicine, organ function level must conform to the requirements;
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
• The urine protein + 2 or 1000 mg / 24 h or less or less;
• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Критерии исключения

• Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients with systemic chemotherapy; Stage 2 patients who had received previous systemic therapy;
• In the second stage queue one signed informed consent before gene sequencing report suggests patients such as mutation of ALK fusion;
• Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Fluorouracil class oral drugs, etc.;
• Serious heart disease;
• Long QT, complete left bundle branch block, III degree atrioventricular block; Serious arrhythmia;
• Active autoimmune and inflammatory diseases;
• Before the first delivery within 5 years diagnosed as other malignant tumor;
• Two antihypertensive drugs poorly controlled hypertension;
• Patients with poor glycemic control;
• With a history of ILD, current ILD or suspected suffering from such diseases during screening;
• Complicated with pulmonary diseases leading to severe respiratory function impairment;
• There is a lot of serous cavity effusion, or have a serous cavity effusion and has symptoms, or poorly controlled serous cavity effusion patients;
• Imaging studies suggest tumor has violated or package around the chest, neck, pharyngeal large blood vessels;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• Active central nervous system of patients;
• For restructuring or human mouse chimeric antibody on study of humanized anti-platelet antibody has a history of allergies or allergic to BL - B01D1 any supplementary material composition of patients;
• Before transplant or allogeneic hematopoietic stem cell transplantation (Allo - HSCT);
• Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• Active infection requiring systemic therapy;
• Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
• Had participated in another clinical trial within 4 weeks before the first dose;
• Other conditions for trial participation were not considered appropriate by the investigator.

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

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06475300 · BL-B01D1-204-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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