NCT05127759进行中（未招募）2 期
An Open Label, Multicenter Phase II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年3月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Good Organ Function;
- •Expected survival time ≥ 3 months;
- •Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;
- •At least one measurable lesion as per RECIST v1.1;
- •ECOG score 0-1.
排除标准
- •Previous treatment with BRAF inhibitors or MEK inhibitors
- •Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 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
HLX208
Experimental
Participants receive HLX208 450mg bid po
干预措施: HLX208 (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
- PFS(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years)
- OS(from the date of first dose until the date of death from any cause，assessed up to 2 years)
研究者
研究点 (1)
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