NCT07597759CompletedPhase 1
A Clinical Study Evaluating the Safety, Tolerability, Biodistribution and Radiation Dose Measurement of 68Ga-NODAGA-SNA009 in Patients With Colorectal Cancer
SmartNuclide Biopharma1 site in 1 country12 target enrollmentStarted: October 30, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Group1
Experimental
0.1mg
Intervention: 68Ga-NODAGA-SNA009 (Drug)
Group 2
Experimental
0.3mg
Intervention: 68Ga-NODAGA-SNA009 (Drug)
Group 3
Experimental
0.5mg
Intervention: 68Ga-NODAGA-SNA009 (Drug)
Group 4
Experimental
0.9mg
Intervention: 68Ga-NODAGA-SNA009 (Drug)
Investigators
Study Sites (1)
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