NCT07208136招募中1 期
An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JMKX005425 Tablets in Subjects With Microsatellite Instability-High or Mismatch Repair Deficient Advanced Solid Tumors
Jemincare1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年10月22日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs)
研究概览
简要总结
This is a first-in-human, Phase I, open-label, multi-center, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JMKX005425 in subjects with microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR) advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR), histologically or cytologically documented advanced solid tumor.
- •Has at least one measurable lesion per RECIST v1.
- •Has a life expectancy of ≥ 12 weeks.
- •Adequate organ function.
排除标准
- •Toxicities from prior anti-tumor therapy has not recovered to Grade 1 or below per CTCAE v5.
- •History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
- •Has the dysphagia, or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug.
- •Has the severe chronic or active infection
- •Has a history of severe cardiovascular disease.
- •Subject is pregnant or breastfeeding.
研究组 & 干预措施
JMKX005425
Experimental
Subjects will take a pre-specified dose of JMKX005425.
干预措施: JMKX005425 (Drug)
结局指标
主要结局
Number of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs)
时间窗: up to 2 years
To assess the safety and tolerability of JMKX005425.
次要结局
- maximum plasma concentration (Cmax)(Up to 2 months)
- maximum plasma concentration (Tmax)(Up to 2 months)
- Objective Response Rate (ORR)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
研究者
研究点 (1)
Loading locations...
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