NCT05114603Unknown2 期
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation
Shanghai Henlius Biotech7 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月21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
- 30
- 试验地点
- 7
- 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 advanced melanoma with BRAF V600 mutation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 melanoma with BRAF V600 mutation that have been diagnosed
- •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 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable).
- •Severe active infections requiring systemic anti-infective therapy
- •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
Dose-escalation stage
Experimental
Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.
干预措施: HLX208 (Drug)
Dose-expansion stage
Experimental
Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208.
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(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years)
- 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) assessed up to 1 years)
- OS(from the first dose to the time of death due to any cause，assessed up to 2 years)
研究者
研究点 (7)
Loading locations...
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