NCT05092802Unknown2 期
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Refractory Primary Brain Tumors With BRAF Mutation
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12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
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation
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
- •Age>=18Y
- •Good Organ Function
- •Expected survival time ≥ 3 months
- •Refractory primary brain tumors with BRAF mutation that have been diagnosed
- •Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy
- •ECOG score 0-1;
排除标准
- •Previous treatment with BRAF inhibitors or MEK inhibitors
- •A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery
- •Severe active infections requiring systemic anti-infective therapy
- •Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
研究组 & 干预措施
HLX208
Experimental
干预措施: HLX208 (Drug)
结局指标
主要结局
ORR
时间窗: from first dose to the last patient was followed up for 6 month
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RANO
次要结局
- OS(from the first dose to the time of death due to any cause，an average of about 2 year)
- PFS(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year)
- DOR(from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first)，an average of about 1 year)
研究者
研究点 (1)
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