NCT06535009终止1 期
A Phase I, Open-label, Uncontrolled, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7914 Alone and in Combination 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
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adverse Events as assessed by CTCAE v5.0
研究概览
简要总结
This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination 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
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced or metastatic solid tumor
- •Patients with ECOG performance status of 0 or 1
- •Patients with a life expectancy of at least 3 months
排除标准
- •Patients with severe complication
- •Patients judged to be incapable of providing consent for reasons such as concurrent dementia
研究组 & 干预措施
ONO-7914
Experimental
干预措施: ONO-7914 (Drug)
ONO-7914+ONO-4538
Experimental
干预措施: ONO-7914 (Drug)
ONO-7914+ONO-4538
Experimental
干预措施: ONO-4538 (Drug)
结局指标
主要结局
Adverse Events as assessed by CTCAE v5.0
时间窗: Up to 28 days after the completion of treatment period
Dose Limiting Toxicity
时间窗: 28 days
次要结局
- Urine concentration of ONO-7914(Up to 24 hours after the first treatment)
- Plasma concentration of ONO-7914(Up to 21 days after the first treatment)
- Serum concentration of ONO-4538(Up to 28 days after the completion of treatment period)
研究者
研究点 (1)
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