Phase IIT Trial of SNA009
May 13, 2026 updated by: SmartNuclide Biopharma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
12
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 300000
- Tianjin Medical University Cancer Institute and Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group1
0.1mg
|
68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
|
|
Experimental: Group 2
0.3mg
|
68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
|
|
Experimental: Group 3
0.5mg
|
68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
|
|
Experimental: Group 4
0.9mg
|
68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The safety and tolerability in patients with advanced colorectal cancer.
Time Frame: 1 week
|
Occurrence of AE/SAE according to CTCAE 5.0
|
1 week
|
|
The safety and tolerability in patients with advanced colorectal cancer.
Time Frame: 1 week
|
Occurrence of abnormal Laboratory tests after administration
|
1 week
|
|
The safety and tolerability in patients with advanced colorectal cancer.
Time Frame: 1 week
|
Occurrence of abnormal Vital signs after administration
|
1 week
|
|
The safety and tolerability in patients with advanced colorectal cancer.
Time Frame: 1 week
|
Occurrence of abnormal Physical examination after administration
|
1 week
|
|
The safety and tolerability in patients with advanced colorectal cancer.
Time Frame: 1 week
|
Occurrence of abnormal ECG after administration
|
1 week
|
|
The radiation characters in patients with colorectal cancer
Time Frame: 4 hours
|
radiological absorption dose of major organs
|
4 hours
|
|
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Time Frame: 4 hours
|
SUVmax of major organs and tumors
|
4 hours
|
|
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Time Frame: 4 hours
|
SUVmean of major organs and tumors
|
4 hours
|
|
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Time Frame: 4 hours
|
Retention time of major organs and tumors
|
4 hours
|
|
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Time Frame: 4 hours
|
Percentage of injection dose (ID%) of major organs and tumors
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2025
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
April 21, 2026
First Submitted That Met QC Criteria
May 13, 2026
First Posted (Actual)
May 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNA009-202501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.