Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 183
- 试验地点
- 23
- 主要终点
- Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
研究概览
简要总结
The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or metastatic solid tumors (Part A, B)
- •Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
- •Unresectable, advanced or recurrent colorectal cancer(Part D)
- •Life expectancy of at least 3 months
- •Patients with ECOG performance status 0 or 1
排除标准
- •Patients with severe complication
- •Patients with multiple primary cancers
研究组 & 干预措施
Part A (Dose Escalation Part): ONO-4578 monotherapy
ONO-4578 specified dose on specified days in advanced or metastatic solid tumors
干预措施: ONO-4578 (Drug)
Part C (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer
干预措施: ONO-4538 (Drug)
Part B: ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors
干预措施: ONO-4538 (Drug)
Part B: ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors
干预措施: ONO-4578 (Drug)
Part D (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer
干预措施: ONO-4578 (Drug)
Part D (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer
干预措施: ONO-4538 (Drug)
Part C (Expansion Part): ONO-4578 in combination with ONO-4538
ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer
干预措施: ONO-4578 (Drug)
结局指标
主要结局
Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
时间窗: Through study completion, an average of 1 year
次要结局
- Area Under the blood concentration-time Curve(AUC)(Up to Cycle 1 (each cycle is 28 days))
- Maximum observed serum concentration(Cmax)(Up to Cycle 1 (each cycle is 28 days))
- Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538(Up to Cycle 1 (each cycle is 28 days))