NCT03730337已完成1 期
Open-label, Uncontrolled, Dose-escalation Study of ONO-7475 Given as Monotherapy and Combinations With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety
研究概览
简要总结
To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
- •ECOG Performance Status 0～1
- •Patients with life expectancy of at least 3 months
排除标准
- •Patients with history of severe allergy
- •Patients with multiple cancers
研究组 & 干预措施
ONO-7475 monotherapy
Experimental
干预措施: ONO-7475 (Drug)
ONO-7475 in combination with ONO-4538
Experimental
干预措施: ONO-7475 + ONO-4538 (Drug)
结局指标
主要结局
Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety
时间窗: Through study completion, an average of 1 year
Number of paticipants with dose-limiting toxicities during the DLT evaluation period
时间窗: 28 days
次要结局
- Pharmacokinetics (Cmax)(Through study completion)
- Pharmacokinetics (AUC)(Through study completion)
- Pharmacokinetics (Tmax)(Through study completion)
研究者
研究点 (1)
Loading locations...
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