NCT07597759已完成1 期
A Clinical Study Evaluating the Safety, Tolerability, Biodistribution and Radiation Dose Measurement of 68Ga-NODAGA-SNA009 in Patients With Colorectal Cancer
SmartNuclide Biopharma1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年10月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
This clinical trial is a single-center, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics and radiation dosimetry of 68Ga-NODAGA-SNA009 in patients with colorectal cancer.
详细描述
68Ga-NODAGA-SNA009 is a radiopharmaceutical that targets GPA33. This study aims to assess the correlation between radiological imaging results and the pathological expression of GPA33.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years (inclusive);
- •Participants must have legal capacity, voluntarily agree to participate in this clinical trial, and have signed an informed consent form (ICF);
- •Patients with a confirmed diagnosis of colorectal cancer;
- •Results of colonoscopy, CT, MRI or PET-CT scans performed within the past month (if available);
- •Pathology test results from within the past year
排除标准
- •Patients with other clearly diagnosed malignant tumours;
- •Patients with uncontrolled severe infections, or those with other serious comorbidities;
- •Patients with a life expectancy of ≤3 months;
- •Pregnant or breastfeeding patients, and patients of childbearing potential who refuse to use appropriate contraception during the trial;
- •Patients deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
Group1
Experimental
0.1mg
干预措施: 68Ga-NODAGA-SNA009 (Drug)
Group 2
Experimental
0.3mg
干预措施: 68Ga-NODAGA-SNA009 (Drug)
Group 3
Experimental
0.5mg
干预措施: 68Ga-NODAGA-SNA009 (Drug)
Group 4
Experimental
0.9mg
干预措施: 68Ga-NODAGA-SNA009 (Drug)
研究者
研究点 (1)
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