A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC
详细描述
This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Males and/or females over age 18
- •Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Expected survival >=3 months.
- •Signed informed consent form.
排除标准
- •Known uncontrolled or symptomatic central nervous system metastatic disease.
- •Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).
- •Inadequate organ or bone marrow function.
- •Pregnant or breast-feeding woman.
- •Known allergies, hypersensitivity, or intolerance to SSGJ-706
- •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
dose level 1 of SSGJ-706 monotherapy
干预措施: SSGJ-706 (Drug)
dose level 2 of SSGJ-706 monotherapy
干预措施: SSGJ-706 (Drug)
dose level 1 of SSGJ-706 combined with chemotherapy
干预措施: SSGJ-706 (Drug)
dose level 1 of SSGJ-706 combined with chemotherapy
干预措施: pemetrexed /carboplatin (Drug)
dose level 2 of SSGJ-706 combined with chemotherapy
干预措施: SSGJ-706 (Drug)
dose level 2 of SSGJ-706 combined with chemotherapy
干预措施: Carboplatin/Paclitaxel (Drug)
PD-1/L1 combined with chemotherapy
干预措施: PD-1 Inhibitor + Chemotherapy (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 12 months
Incidence and severity of Adverse Events
时间窗: 12 months
次要结局
- DCR : Disease Control Rate(12 months)
- PFS：Progression-Free Survival(24 month)
- OS：Overall Survival(24 month)
- The blood concentration of SSGJ-706(Approximately 6 months)
- The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)(Approximately 6 months)