NCT07559019招募中1 期
Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants With Advanced Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
This study is a multi-regional, open-label phase I study to evaluate the Safety, Tolerability, and Efficacy of IBI115 as Monotherapy and in Combination Therapy in Participants with Advanced 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
- •Participants must be able to understand and sign the written informed consent form for participation in this trial, including all evaluations and procedures specified in this protocol.
- •Male or female participants aged ≥18 years and ≤75 years.
- •Participants with histologically or cytologically confirmed advanced small cell lung cancer.
- •At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Expected survival period ≥12 weeks.
- •Adequate bone marrow and organ function confirmed during the screening period.
排除标准
- •Concurrent participation in another interventional clinical study, except for observational non-interventional studies or being in the survival follow-up phase of an interventional study.
- •Administration of a live vaccine within 4 weeks prior to the first dose of the study drug or a cancer vaccine within 3 months prior, or planning to receive any live vaccine during the study period.
- •Adverse reactions from prior anti-tumor therapy that have not resolved to CTCAE v6.0 Grade 0, Grade 1, or baseline levels by the time of the first dose of the study drug.
- •Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.
研究者
研究点 (1)
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