jRCT2031220477招募中不适用
A Phase 1 study of RN-1101 in patients with solid tumor
RIN Institute Inc.0 个研究点目标入组 73 人开始时间: 2023年1月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 73
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Cytologically- or histologically-confirmed diagnosis of a locally advanced or metastatic solid tumor (In the expansion cohort, it is limited to colon or rectal cancer.)
- •Refractory to or intolerable with standard treatment, or for which no standard treatment is available
- •Age 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
- •Willing and able to provide informed consent
- •Mesureable disease per RECIST version 1.1
排除标准
- •Has multiple primary malignancies within 2 years
- •Has clinically active brain metastases
- •Has a history of Interstitial pneumonia
- •Known HIV infection
- •Known ative hapatitis B or C infection
- •Is pregnant as confirmed or possible, or a lactating mother
结局指标
主要结局
-
DLT
次要结局
未报告次要终点
研究者
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