NCT05092815进行中（未招募）2 期
A Single-arm, Open Label, Multicenter Phase II Clinical Study in Rare Diseases to Evaluate Safety, Efficacy and PK of HLX208 for Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) 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: 2021年12月6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 safety, efficacy and PK in adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) 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
- •Volunteer to participate in the clinical study;
- •Aged ≥ 18 years;
- •Confirmed adult patients with LCH and/or ECD with BRAF V600E mutation;
- •At least one measurable lesion as per PERCIST v1.0;
- •Expected survival time ≥ 3 months;
- •ECOG score 0-2;
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
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 1 year
Objective response rate(assessed by independent review committee (IRC) based on the PERCIST Version 1.0)
次要结局
- AEs(up to 1 year)
- Tmax(from the date of first dose to 85 days)
- DCR(up to 1 year)
- ORR(up to 1 year)
- Cmax(from the date of first dose to 85 days)
- AUC(from the date of first dose to 85 days)
- TTR(up to 1 year)
- PFS(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 1 year)
- OS(from the date of first dose until the date of death from any cause，assessed up to 1 year)
研究者
研究点 (1)
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