NCT07364422尚未招募1 期
A Multicenter, Open-label, Single-arm, Dose-finding and Expansion Phase 1b/2 Study to Evaluate the Safety and Tolerability of JPI-547 in Combination With Irinotecan as a Third Line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- 1b: dose-limiting toxicity rate
研究概览
简要总结
This study aims to evaluate the safety and tolerability of JPI-547 in combination with irinotecan as a third-line and beyond therapy for recurrent or metastatic gastric cancer
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after second-line therapy.
- •Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Those with at least one measurable lesion in accordance with RECIST 1.1
排除标准
- •Patients with a confirmed specific medical history or past surgical history
- •Patients who meet specific criteria regarding prior treatment
- •Patients with a history of specific drug administration
- •Patients with specific comorbidities.
- •Patients who have undergone major surgery within 4 weeks prior to screening or are expected to require major surgery during the clinical trial are excluded. (However, those who have had minor surgeries
- •Patients with symptoms at the time of screening, who have not received treatment, or who have rapidly progressing central nervous system (CNS) metastases.
- •Patients with mental disorders or altered mental status/consciousness (AMS) that impair their ability to understand this clinical trial for informed consent.
- •Pregnant or Lactating Women
- •Subjects with a history of severe allergic anaphylactic reactions to the investigational product and/or its components, or who have contraindications to the administration of the investigational product and/or irinotecan
- •Patients considered unsuitable for this clinical trial by the investigator.
研究组 & 干预措施
JPI-547 and Irinotecan
Experimental
coadministration of JPI-547 and Irinotecan
干预措施: JPI-547 (Drug)
JPI-547 and Irinotecan
Experimental
coadministration of JPI-547 and Irinotecan
干预措施: Irinotecan (drug) (Drug)
结局指标
主要结局
1b: dose-limiting toxicity rate
时间窗: The dose-limiting toxicity evaluation window is 28 days from C1D1.
phase 2: Overall Response Rate (ORR) according to RECIST v1.1
时间窗: At 6-week intervals through study completion, an average of 3 years.
次要结局
未报告次要终点
研究者
研究点 (1)
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