NCT04672369已完成1 期
An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed the Informed Consent Form;
- •Male or female ≥ 18 and≤75 years of age;
- •Life expectancy ≥ 12 weeks;
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
- •Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
- •Histologically or cytologically confirmednon-small cell lung cancer
排除标准
- •Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
- •Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
- •Received any investigational agent within 4 weeks prior to the first dose of study drug;
- •Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
- •Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
研究组 & 干预措施
IBI939 in combination with Sintilimab
Experimental
干预措施: IBI939 (Biological)
sintilimab
Active Comparator
干预措施: Sintilimab (Biological)
IBI939 in combination with Sintilimab
Experimental
干预措施: Sintilimab (Biological)
结局指标
主要结局
Objective response rate(ORR)
时间窗: 6 months
Proportion of subjects with complete response(CR) or partial response(PR).
次要结局
- adverse event(3 months)
- Half-life (t1/2)(24 hours)
- Overall Survival(OS)(6 months)
- Time to Objective Response(TTR)(6 months)
- Area under the plasma concentration-time curve (AUC)(24 hours)
- Trough concentration (Cmin)(24 hours)
- Progression-free survival(PFS)(6 months)
- Disease Control Rate(DCR)(6 months)
- Duration of Response (DoR)(6 months)
- Clearance (CL), 12. volume of distribution (V)(24 hours)
- Maximum concentration (Cmax)(24 hours)
研究者
研究点 (1)
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