Pancreatic CancerEarly Phase 1NCT07597772
Preliminary Trial of SNA014 for Pancreatic Cancer
A Early Phase 1 study testing 68Ga-NODAGA-SNA006 in people with Pancreatic Cancer, run by SmartNuclide Biopharma at 1 site in China.
Trial summary
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- 68Ga-NODAGA-SNA006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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);
- Possessing legal capacity, voluntarily participating in this clinical trial, and having signed the informed consent form (ICF);
- Patients with a confirmed diagnosis of pancreatic cancer whose tumours are suitable for Claudin-18.2 testing;
- Results of gastroscopy, 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
Tianjin Medical University Cancer Institute and Hospital
About this study
Official title: A Clinical Study on the Use of ⁶⁸Ga-labelled Claudin 18.2 as a Contrast Agent in Combination With PET/CT for the Imaging of Pancreatic Cancer
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for pancreatic cancer
- Conditions
- Pancreatic Cancer
- Being tested
- 68Ga-NODAGA-SNA006
- Keywords
- Pancreatic cancer, 68Ga, Claudin 18.2
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-SNA006Drug
Administration
| Study group | Role | What they receive |
|---|---|---|
| Group | Experimental | 68Ga-NODAGA-SNA006 Receives: Drug: 68Ga-NODAGA-SNA006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability profile of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.
Occurrence of AE/SAE according to CTCAE 5.0
Measured: 1 week
CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.
SUVmax of tumors
Measured: 1 week
CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.
SUVmean of tumors
Measured: 1 week
CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.
Correlation of tumor uptakes and Immunohistochemistry
Measured: 1 week
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 start1 Oct 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SmartNuclide Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597772
- Sponsor's protocol ID
- SNA014-202501
- 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 on the Use of ⁶⁸Ga-labelled Claudin 18.2 as a Contrast Agent in Combination With PET/CT for the Imaging of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07597772
- Acronym / sponsor ID
- SNA014-202501
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, 68Ga, Claudin 18.2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- SmartNuclide BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- 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.
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for pancreatic cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | Experimental | Drug: 68Ga-NODAGA-SNA00668Ga-NODAGA-SNA006 |
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);
- Possessing legal capacity, voluntarily participating in this clinical trial, and having signed the informed consent form (ICF);
- Patients with a confirmed diagnosis of pancreatic cancer whose tumours are suitable for Claudin-18.2 testing;
- Results of gastroscopy, 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-SNA006Administration | Drug | Group |
Primary outcome
The safety and tolerability profile of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.
Time frame: 1 week
Occurrence of AE/SAE according to CTCAE 5.0
CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.
Time frame: 1 week
SUVmax of tumors
CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.
Time frame: 1 week
SUVmean of tumors
CLDN18.2-targeting ability of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer.
Time frame: 1 week
Correlation of tumor uptakes and Immunohistochemistry
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
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-SNA006 in people with Pancreatic Cancer, 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Dai, Doctor (022-23340123, 1014481959@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability profile of [68Ga]Ga-NODAGA-SNA014 in patients with CLDN18.2-positive pancreatic cancer. (time frame: 1 week). The study lists 4 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.