NCT04403308已完成1 期
An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.
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
- 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 of 0-1
- •Patients with life expectancy of at least 3 months
排除标准
- •Patients with multiple cancers
- •Patients with history of serious allergy
结局指标
主要结局
Adverse events
时间窗: Up to 24 months
Assessed by the NCI CTCAE v5.0 criteria
Dose-limiting toxicities
时间窗: 28 days
Number of participants with a DLT
次要结局
- Concentration vs time of ONO-7913 as single dose(Up to 24 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid TumorsSolid TumorNCT03182257Ono Pharmaceutical Co. Ltd1
终止
1 期
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid TumorsSolid TumorNCT06535009Ono Pharmaceutical Co. Ltd25
已完成
1 期
Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsNCT03730337Ono Pharmaceutical Co. Ltd24
进行中（未招募）
1 期
An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic CancerMetastatic Pancreatic CancerNCT06532344Ono Pharmaceutical Co. Ltd32
进行中（未招募）
1 期
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal CancerUnresectable Colorectal CancerNCT06540261Ono Pharmaceutical Co. Ltd65