NCT06548217进行中（未招募）1 期
An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- Dose-limiting toxicities (DLT)
研究概览
简要总结
This is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.
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
- •Patient with advanced or metastatic solid tumors
- •Patients have an ECOG performance status of 0 to 1
- •Patients with a life expectancy of at least 3 months
- •[Tolerability confirmation part]
- •Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available
- •[Expansion part]
- •Patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert
排除标准
- •Patients with a complication or history of severe hypersensitivity to any antibody product
- •Patients with severe complication
研究组 & 干预措施
ONO-4538HSC
Experimental
干预措施: ONO-4538HSC (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLT)
时间窗: 28 days
Adverse event (AE)
时间窗: UP to 100 days after the last dose
次要结局
- Pharmacokinetics（serum concentration of Nivolumab）(Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase))
研究者
研究点 (8)
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