Phase IIT Trial of SNA009

A Clinical Study Evaluating the Safety, Tolerability, Biodistribution and Radiation Dose Measurement of 68Ga-NODAGA-SNA009 in Patients With Colorectal Cancer

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.

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.

Inclusion Criteria:

1. Aged between 18 and 75 years (inclusive);
2. Participants must have legal capacity, voluntarily agree to participate in this clinical trial, and have signed an informed consent form (ICF);
3. Patients with a confirmed diagnosis of colorectal cancer;
4. Results of colonoscopy, CT, MRI or PET-CT scans performed within the past month (if available);
5. Pathology test results from within the past year

Exclusion Criteria:

1. Patients with other clearly diagnosed malignant tumours;
2. Patients with uncontrolled severe infections, or those with other serious comorbidities;
3. Patients with a life expectancy of ≤3 months;
4. Pregnant or breastfeeding patients, and patients of childbearing potential who refuse to use appropriate contraception during the trial;
5. Patients deemed unsuitable for participation in this study by the investigator.