An Open, Multicenter Phase II Clinical Study to Evaluate Safety and Efficacy of HLX208 (BRAF V600E Inhibitor) Combined With Cetuximab in Patients With Metastatic Colorectal Cancer (mCRC)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>=18Y
- •Good Organ Function
- •Expected survival time ≥ 3 months
- •Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment
- •ECOG score 0-1;
排除标准
- •arm 1 ： Previous treatment with BRAF inhibitors or MEK inhibitors
- •Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- •Active clinical severe infection;
- •A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
研究组 & 干预措施
Never use other BRAF inhibitor therapy
Never use other BRAF inhibitor therapy
干预措施: HLX208 (Drug)
Never use other BRAF inhibitor therapy
Never use other BRAF inhibitor therapy
干预措施: Cetuximab Injection [Erbitux] (Drug)
PD after other BRAF inhibitor therapy N=5~40
PD after other BRAF inhibitor therapy
干预措施: HLX208 (Drug)
PD after other BRAF inhibitor therapy N=5~40
PD after other BRAF inhibitor therapy
干预措施: Cetuximab Injection [Erbitux] (Drug)
SD but intolerant after other BRAF inhibitor therapy
SD but intolerant after other BRAF inhibitor therapy
干预措施: HLX208 (Drug)
SD but intolerant after other BRAF inhibitor therapy
SD but intolerant after other BRAF inhibitor therapy
干预措施: Cetuximab Injection [Erbitux] (Drug)
结局指标
主要结局
ORR
时间窗: up to 2 years
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
次要结局
- OS(from the date of first dose until the date of death from any cause，assessed up to 2 years)
- PFS(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years])