临床试验/NCT05528406

NCT05528406尚未招募2 期

An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation

Shanghai Henlius Biotech0 个研究点目标入组 30 人开始时间: 2022年10月20日最近更新: 2022年9月6日

适应症

干预措施

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 30
主要终点: ORR

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 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
•advanced solid tumors with BRAF V600 mutation that have been diagnosed
•Previous failure to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
•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 beenon > treatment for 6 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable)
•A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin
•Patient with non-small cell lung cancer, anaplastic thyroid cancer, malignant primary intracranial tumor, melanoma, colorectal cancer or hematological tumor（Vulva and vaginal melanoma are excluded.）
•Severe active infections requiring systemic anti-infective therapy

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 e RECIST Version 1.1)

次要结局

PFS([Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years])
OS([Time Frame: from the first dose to the time of death due to any cause，assessed up to 2 years])
DOR([Time Frame: 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) assessed up to 1 years])

研究者

发起方

Shanghai Henlius Biotech

申办方类型

Industry

责任方

Sponsor

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