NCT07110363尚未招募1 期
An Open-label Phase Ib Study on the Safety, Tolerability, and Efficacy of BT02 in Treating Patients With Advanced Lung Cancer
未提供0 个研究点目标入组 58 人开始时间: 2025年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 58
- 主要终点
- Dose limited toxicity incidence
研究概览
简要总结
The goal of this clinical trial is to assess whether an investigational treatment is safe and tolerable for patients with advanced lung cancer, and to get a preliminary idea of its effectiveness. Participants of all genders, aged between 18 and 75(inclusive), are eligible to join. These patients will receive the investigational drug intravenously every two weeks. If their condition doesn't worsen and they don't experience unbearable side effects, they can continue the treatment for up to two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Patients with pathologically confirmed locally advanced/unresectable or metastatic or recurrent non-small cell lung cancer (NSCLC, according to AJCC TNM staging) and advanced/unresectable limited-stage or extensive-stage small cell lung cancer (SCLC, according to VALG combined with AJCC TNM staging)，who have failed in the prior systemic therapy .
- •Adequate organ and hematologic function.
- •At least 1 extracranial measurable lesion.
- •An ECOG activity status score of 0-
- •A life expectancy of ≥ 3 months.
- •Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
- •Good compliance and willingness to follow up.
排除标准
- •Patients with sensitive mutations or gene fusions related to lung cancer.
- •Prior to the first dose , received systemic antitumor therapy, scheduled major surgical procedure within 4 weeks, received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
- •A history of active autoimmune disease within the past 2 years.
- •A history of clinically significant cardiovascular disease, severe cardiac rhythm /conduction abnormalities or LVEF <50% . A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
- •A severe acute or chronic infection when enrollment.
- •Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
- •Unresolved > Grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
- •Clinically active CNS metastases or meningeal metastases.
- •A history of other type of malignancies.
- •Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
- •Poor compliance.
- •A history of alcohol or drugs abuse.
- •Current pregnancy or breastfeeding.
- •Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.
研究组 & 干预措施
dose escalation and expansion
Experimental
干预措施: BT02 (Drug)
结局指标
主要结局
Dose limited toxicity incidence
时间窗: Through the dose escalation phase , an average of 8 months
Adverse events
时间窗: through study completion, an average of 2 years
Maximum tolerated dose(MTD)
时间窗: Through the dose escalation phase, an average of 8 months
Recommended Phase II dose (RP2D)
时间窗: Through study completion, an average of 2 years
次要结局
- Objective response rate (ORR) on tumor assessments(Through the study completion, an average of 2 years)
- Overall survival (OS) on tumor assessments(Through the study completion, an average of 2 years)
- Duration of response (DoR) on tumor assessments(Through the study completion, an average of 2 years)
- Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level(Through study completion, an average of 2 years)
- Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level(Through study completion, an average of 2 years)
- Progression-free survival (PFS) on tumor assessments(Through the study completion，an average of 2 years)
- Disease control rate (DCR) on tumor assessments(Through the study completion, an average of 2 years)
- ADA and NAb incidence(Through the study completion, an average of 2 years)
研究者
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