NCT06532331进行中（未招募）1 期
A PhaseⅠStudy to Examine Tolerability and Safety of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and Safety of ONO-7475 in Combination With GnP in Patients With Metastatic Pancreatic Cancer as First-line Treatment
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
- 87
- 试验地点
- 9
- 主要终点
- Dose-limiting toxicities (DLT)
研究概览
简要总结
This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 metastatic pancreatic cancer
- •Patients have an ECOG performance status of 0 to 1
- •Patients with a life expectancy of at least 6 months
排除标准
- •Patients are unable to swallow oral medications
- •Patients with severe complication
研究组 & 干预措施
ONO-7475+GnP
Experimental
干预措施: ONO-7475 (Drug)
ONO-7475+GnP
Experimental
干预措施: Nab-paclitaxel (Drug)
ONO-7475+GnP
Experimental
干预措施: Gemcitabine (Drug)
ONO-7475＋ONO-4538＋GnP
Experimental
干预措施: ONO-7475 (Drug)
ONO-7475＋ONO-4538＋GnP
Experimental
干预措施: ONO-4538 (Drug)
ONO-7475＋ONO-4538＋GnP
Experimental
干预措施: Nab-paclitaxel (Drug)
ONO-7475＋ONO-4538＋GnP
Experimental
干预措施: Gemcitabine (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 28 days after the last dose
次要结局
- Pharmacokinetics (Plasma concentration of ONO-7475)(Up to Cycle16)
- Best Overall Response (BOR)(Through study completion, an average of 6 months)
- Objective Response Rate (ORR)(Through study completion, an average of 6 months)
- Overall Survival (OS)(Through study completion, an average of 1 year)
- Disease Control Rate (DCR)(Through study completion, an average of 6 months)
- Progression-Free Survival (PFS)(Through study completion, an average of 6 months)
- Percent change in the sum diameters of the target lesions(Through study completion, an average of 6 months)
- CEA(Through study completion, an average of 6 months)
- Pharmacokinetics (Plasma concentration of ONO-4538)(Through study completion, an average of 6 months)
- Anti-ONO-4538 antibody(Through study completion, an average of 6 months)
- Duration of Response (DOR)(Through study completion, an average of 6 months)
- CA19-9(Through study completion, an average of 6 months)
- Maximum percent change in the sum diameters of the target lesions(Through study completion, an average of 6 months)
- Time to Response (TTR)(Through study completion, an average of 6 months)
研究者
研究点 (9)
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