NCT07196410招募中1 期
A Phase I Study of KAN-004 in Patients With Immune-Related Diarrhea or Colitis
Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2026年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events; Safety and tolerability of KAN-004
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of solid tumor treated with immune checkpoint inhibitor (≥1 cycle, ≤180 days since last cycle).
- •Clinical diagnosis of irColitis (CTCAE >grade 2).
- •Age ≥18 years
- •Able to ingest capsules.
- •Consent to provide blood and stool samples.
- •Accessible for treatment and follow-up.
- •Agreement to use highly effective contraception if of childbearing potential.
排除标准
- •Prior/concurrent malignancy that could interfere with safety/efficacy assessment.
- •Colostomy.
- •Prior diagnosis of malabsorption.
- •Untreated chronic hepatitis B or C.
- •Solid organ transplant recipients.
- •HIV-positive status.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Participants with steroid-naïve irColitis
Experimental
Participants with non-steroid refractory irColitis
干预措施: KAN-004 (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events; Safety and tolerability of KAN-004
时间窗: 6 weeks of treatment
Proportion of participants with non-steroid refractory irColitis experiencing adverse events as measured by CTCAE v5.
Safety and tolerability of KAN-004
时间窗: 6 weeks of treatment
Proportion of participants with non-steroid refractory irColitis experiencing adverse events as measured by CTCAE v5.
次要结局
未报告次要终点
研究者
研究点 (2)
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