A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 10
- 主要终点
- Dose limiting toxicities (DLTs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.
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
- •Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
- •Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- •Minimum life expectancy of ≥ 12 weeks;
- •Adequate organ function confirmed at screening period;
- •Histologically or cytologically confirmed unresectable,metastatic or Extensive-Stage small cell lung cancer (SCLC).
- •Exclusion Criteria
- •Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
- •Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator's discretion) prior to the first dose of the study drug;
- •Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;
- •Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.;
- •Women who are pregnant, have positive results in pregnancy test or are lactating;
- •Not eligible to participate in this study at the discretion of the investigator.
排除标准
- 未提供
研究组 & 干预措施
IBI3009
干预措施: IBI3009 (Drug)
结局指标
主要结局
Dose limiting toxicities (DLTs)
时间窗: Up to 28 days
Dose limiting toxicities (DLTs) to establish MTD and/or RDE.
Number of subjects with clinically significant changes in physical examination results
时间窗: Up to 3 years
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in electrocardiogram
时间窗: Up to 3 years
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Numbers of subjects with adverse events
时间窗: Up to 3 years
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with clinically significant changes in vital signs
时间窗: Up to 3 years
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
次要结局
- area under the curve (AUC)(Up to 3 years)
- maximum concentration (Cmax)(Up to 3 years)
- time to maximum concentration (Tmax)(Up to 3 years)
- clearance (CL)(Up to 3 years)
- apparent volume of distribution (V)(Up to 3 years)
- half-life (t1/2)(Up to 3 years)
- anti-drug antibody (ADA)(Up to 3 years)
- objective response rate (ORR)(Up to 3 years)
- time to response (TTR)(Up to 3 years)
- duration of response (DoR)(Up to 3 years)
- progression free survival (PFS)(Up to 3 years)
- overall survival (OS)(Through out the study (an average of 3 years))