Colorectal CancerEarly Phase 1NCT07597759
Phase IIT Trial of SNA009
A Early Phase 1 study testing 68Ga-NODAGA-SNA009 in people with Colorectal Cancer and GPA33, run by SmartNuclide Biopharma at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, GPA33
- What is being tested?
- 68Ga-NODAGA-SNA009
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, GPA33
- Being tested
- 68Ga-NODAGA-SNA009
- Keywords
- Colorectal cancer, GPA33, Radiopharmaceuticals
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-SNA009Drug
68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | 0.1mg Receives: Drug: 68Ga-NODAGA-SNA009 |
| Group 2 | Experimental | 0.3mg Receives: Drug: 68Ga-NODAGA-SNA009 |
| Group 3 | Experimental | 0.5mg Receives: Drug: 68Ga-NODAGA-SNA009 |
| Group 4 | Experimental | 0.9mg Receives: Drug: 68Ga-NODAGA-SNA009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability in patients with advanced colorectal cancer.
Occurrence of AE/SAE according to CTCAE 5.0
Measured: 1 week
The safety and tolerability in patients with advanced colorectal cancer.
Occurrence of abnormal Laboratory tests after administration
Measured: 1 week
The safety and tolerability in patients with advanced colorectal cancer.
Occurrence of abnormal Vital signs after administration
Measured: 1 week
The safety and tolerability in patients with advanced colorectal cancer.
Occurrence of abnormal Physical examination after administration
Measured: 1 week
The safety and tolerability in patients with advanced colorectal cancer.
Occurrence of abnormal ECG after administration
Measured: 1 week
The radiation characters in patients with colorectal cancer
radiological absorption dose of major organs
Measured: 4 hours
The biodistribution characteristics of 68Ga-NODAGA-SNA009
SUVmax of major organs and tumors
Measured: 4 hours
The biodistribution characteristics of 68Ga-NODAGA-SNA009
SUVmean of major organs and tumors
Measured: 4 hours
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Retention time of major organs and tumors
Measured: 4 hours
The biodistribution characteristics of 68Ga-NODAGA-SNA009
Percentage of injection dose (ID%) of major organs and tumors
Measured: 4 hours
Secondary outcomes (1)
Correlation between imaging and IHC
Correlation of tumors between 68Ga-NODAGA-SNA009 in PET imaging and GPA33 expression levels in patients with colorectal cancer.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start30 Oct 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- SmartNuclide Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597759
- Sponsor's protocol ID
- SNA009-202501
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety, Tolerability, Biodistribution and Radiation Dose Measurement of 68Ga-NODAGA-SNA009 in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07597759
- Acronym / sponsor ID
- SNA009-202501
- Conditions
- Colorectal Cancer, GPA33
- Keywords
- Colorectal cancer, GPA33, Radiopharmaceuticals
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SmartNuclide BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: 68Ga-NODAGA-SNA0090.1mg |
| Group 2 | Experimental | Drug: 68Ga-NODAGA-SNA0090.3mg |
| Group 3 | Experimental | Drug: 68Ga-NODAGA-SNA0090.5mg |
| Group 4 | Experimental | Drug: 68Ga-NODAGA-SNA0090.9mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-SNA00968Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33 | Drug | Group 2, Group 3, Group 4, Group1 |
Primary outcome
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
1 secondary outcome
Correlation between imaging and IHC
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-NODAGA-SNA009 in people with Colorectal Cancer and GPA33, run by SmartNuclide Biopharma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability in patients with advanced colorectal cancer. (time frame: 1 week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.