A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

Официальное название

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

Обзор

This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.

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.

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

• Subject volunteered to participate in the study and signed an informed consent;
• Male or female aged ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• ECOG score 0-1;
• Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology;
• A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of 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

• Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors;
• Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer;
• Pathology suggested small cell carcinoma containing non-small cell carcinoma components;
• Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ;
• Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ;
• QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ;
• Active autoimmune diseases and inflammatory diseases ;
• Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose;
• Other malignancies that have progressed or require treatment within 5 years prior to the first dose;
• Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening;
• Prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; Except for infusion set-related thrombosis;
• Concurrent pulmonary disease leading to severe clinical impairment of respiratory function;
• Patients with active central nervous system metastases;
• Patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions;
• History of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Severe infection within 4 weeks prior to first dose of study drug; Lung infection or active lung inflammation within 4 weeks;
• Have participated in another clinical trial within 4 weeks prior to the first dose;
• Have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders;
• Imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest;
• Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy;
• Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy;
• Subjects who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose;
• Other conditions that the investigator considers unsuitable to participate in this clinical 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

• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT06437509 · BL-B01D1-204-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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