NCT06437509招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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.
排除标准
- •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.
研究组 & 干预措施
Study treatment
Experimental
Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for 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)
Study treatment
Experimental
Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for 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: PD-1 monoclonal antibody (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 24 months
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Recommended Phase II Dose (RP2D)
时间窗: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
次要结局
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)
研究者
研究点 (1)
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