An Open-label, Multicenter, Phase Ib/III Study of Efficacy and Safety of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase
研究概览
简要总结
Phase 1b consists of combined dose escalation phase and dose expansion phase. Phase 3 study will compare efficacy and safety of IBI351 combined with cetuximab versus chemotherapy in treatment of KRAS G12C-mutated metastatic colorectal cancer
详细描述
A Phase 1b study of the safety, tolerability and preliminary efficacy of IBI351 combined with cetuximab in the treatment of KRAS G12C mutant metastatic colorectal cancer will be conducted based on recommended dose of IBI351, which consists of combined dose escalation phase and dose expansion phase. After confirming the efficacy and safety of IBI351 combined with cetuximab in Phase Ib, an open-label Phase 3 study of the efficacy and safety of IBI351 combined with cetuximab versus oxaliplatin-based mFOLFOX6 regimen or irinotecan-based FOLFIRI with or without bevacizumab in treatment of KRAS G12C-mutated metastatic colorectal cancer will be conducted.
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
- •male or female subjects, ≥ 18 years and ≤ 75 years
- •have documentation of KRAS G12C mutation
- •at least one measurable lesion per RECISTv1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •life expectancy of >12 weeks, in the opinion of the investigator
排除标准
- •history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment..
- •history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia.
- •surgical procedures (excluding needle biopsy) performed within 28 days prior to enrollment that may affect the dosing or study assessments in this study.
- •received therapeutic or palliative radiation therapy within 14 days prior to enrollment
- •pregnant or lactating women
研究组 & 干预措施
IBI351
IBI351 recommended dose
干预措施: IBI351 (Drug)
IBI351+Cetuximab
IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W
干预措施: Cetuximab (Drug)
IBI351+Cetuximab
IBI351 recommended dose+Cetuximab 500mg/m2 IV Q2W
干预措施: IBI351 (Drug)
结局指标
主要结局
Incidence of DLTs (Dose-limiting Toxicity) in the Combined Dose Escalation Phase
时间窗: 28 days during the first 4-week cycle
Objective response rate (ORR)
时间窗: Up to 1 year
次要结局
- Number of participants with abnormality in routine urinalysis parameters(up to 30 days after the last administration)
- incidence of serious treatment-emergent AEs (TEAEs) , treatment-related adverse event(TRAE), adverse events (SAEs)(up to 30 days after the last administration)
- Number of participants with abnormality in vital signs(up to 30 days after the last administration)
- Number of participants with abnormality in hematology parameters(up to 30 days after the last administration)
- Number of participants with abnormality in clinical chemistry parameters(up to 30 days after the last administration)
- Number of participants with abnormality in ECG parameters(up to 30 days after the last administration)