Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000, China
Completed
NCT Number: NCT07597759
Phase IIT Trial of SNA009
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Early Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
68Ga-NODAGA-SNA009
Drug68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
Primary outcomes
-
The safety and tolerability in patients with advanced colorectal cancer.
Time frame: 1 week
Occurrence of AE/SAE according to CTCAE 5.0
-
The safety and tolerability in patients with advanced colorectal cancer.
Time frame: 1 week
Occurrence of abnormal Laboratory tests after administration
-
The safety and tolerability in patients with advanced colorectal cancer.
Time frame: 1 week
Occurrence of abnormal Vital signs after administration
-
The safety and tolerability in patients with advanced colorectal cancer.
Time frame: 1 week
Occurrence of abnormal Physical examination after administration
-
The safety and tolerability in patients with advanced colorectal cancer.
Time frame: 1 week
Occurrence of abnormal ECG after administration
-
The radiation characters in patients with colorectal cancer
Time frame: 4 hours
radiological absorption dose of major organs
-
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Time frame: 4 hours
SUVmax of major organs and tumors
-
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Time frame: 4 hours
SUVmean of major organs and tumors
-
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Time frame: 4 hours
Retention time of major organs and tumors
-
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Time frame: 4 hours
Percentage of injection dose (ID%) of major organs and tumors
Secondary outcomes
-
Correlation between imaging and IHC
Time frame: 4 hours
Correlation of tumors between 68Ga-NODAGA-SNA009 in PET imaging and GPA33 expression levels in patients with colorectal cancer.
Sponsors and collaborators
Lead sponsor
SmartNuclide Biopharma
Industry
Collaborators
- Tianjin Medical University Cancer Institute and Hospital
Registry information
Official study title
A Clinical Study Evaluating the Safety, Tolerability, Biodistribution and Radiation Dose Measurement of 68Ga-NODAGA-SNA009 in Patients With Colorectal Cancer
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- May 19, 2026
- Registry last updated
- May 19, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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