Adenocarcinoma of the StomachEarly Phase 1NCT06646783
Phase IIT Trial of SNA014
A Early Phase 1 study testing [68Ga]Ga-NODAGA-SNA014 in people with Adenocarcinoma of the Stomach and Adenocarcinoma of GE Junction, run by SmartNuclide Biopharma at 1 site in China.
Trial summary
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of the Stomach, Adenocarcinoma of GE Junction, Pancreatic Cancer Stage
- What is being tested?
- [68Ga]Ga-NODAGA-SNA014
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 20 Nov 2025
- 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
- Age range of 18 to 75 years old (including boundary values);
- Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
- Diagnosed G/GEJ adenocarcinoma and pancreatic cancer;
- Gastroscopy/CT/MRI/PET-CT examination results within the past month (if any);
- Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).
Who cannot join
- Merge patients with other clearly diagnosed malignant tumors:
- Uncontrolled severe infections or individuals with other serious illnesses;
- Those with an expected survival period of less than or equal to three months;
- Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;
- investigators determine that patients who are not suitable to participate in this study;
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
The First Affiliated Hospital of Soochow University
Jiangsu, Province, 215000
ZhangHua Chief Pharmacist, doctorate, 0512-677-80040, Sdfyy8040@126.com
About this study
Official title: Clinical Study of 68GA-labeled Claudin 18.2 Developer Combined with PET/CT for Imaging of Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer
68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction
- Being tested
- [68Ga]Ga-NODAGA-SNA014
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-NODAGA-SNA014Drug
Perform whole-body PET/CT scans on the subjects at 30 minutes (± 5 minutes), 60 minutes (± 10 minutes), 120 minutes (± 20 minutes), and 240 minutes (± 30 minutes) after administration. Among them, PET scanning can be performed on 1-2 subjects in a certain dose group or each dose group for 30-60 minutes. Among the four CT scans, one CT scan is a conventional low-dose CT scan (120mA), and the remaining three are extremely low-dose CT scans (10-20mA). The main researchers and nuclear medicine physicians can decide whether to change the subsequent image acquisition time and duration of the subjects based on the image information obtained from the enrolled subjects.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | subgroups mass does escalation Receives: Drug: [68Ga]Ga-NODAGA-SNA014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological distribution characteristics
Evaluate the biological distribution characteristics of important organs in the subjects.
- Draw the Volume of Interest (VOI) of the subject's vital organs and calculate the Percentage of Injected Activity (IA) of the vital organs
- Using PMOD software, manually draw regions of interest (VOI) on PET/CT images of the liver, spleen, normal stomach, heart, bone marrow, kidneys, and other areas to obtain the cumulative radioactive activity of these regions. Divide the cumulative radioactive activity by the injection dose to obtain the percentage of injection activity (% IA).
Measured: 1week
Safety tolerance characteristics
AE/SAE/SUSAR
Measured: hrough study completion, an average of 1 year
Secondary outcomes (1)
Metabolic Dynamics Evaluation and Radiation Dose
Detect the radiation dose of whole blood and serum of the subjects, and calculate the absorbed dose of important organs
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the StomachStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT06646783
- Sponsor's protocol ID
- [68Ga]Ga-NODAGA-SNA014
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of 68GA-labeled Claudin 18.2 Developer Combined with PET/CT for Imaging of Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06646783
- Acronym / sponsor ID
- [68Ga]Ga-NODAGA-SNA014
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- SmartNuclide BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 17 Oct 2024 (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 gastric or gastroesophageal junction
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation | Experimental | Drug: [68Ga]Ga-NODAGA-SNA014subgroups mass does escalation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range of 18 to 75 years old (including boundary values);
- Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
- Diagnosed G/GEJ adenocarcinoma and pancreatic cancer;
- Gastroscopy/CT/MRI/PET-CT examination results within the past month (if any);
- Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).
Key exclusion criteria (5 listed)
- Merge patients with other clearly diagnosed malignant tumors:
- Uncontrolled severe infections or individuals with other serious illnesses;
- Those with an expected survival period of less than or equal to three months;
- Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;
- investigators determine that patients who are not suitable to participate in this study;
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]Ga-NODAGA-SNA014Perform whole-body PET/CT scans on the subjects at 30 minutes (± 5 minutes), 60 minutes (± 10 minutes), 120 minutes (± 20 minutes), and 240 minutes (± 30 minutes) after administration. Among them, PET scanning can be performed on 1-2 subjects in a certain dose group or each dose group for 30-60 minutes. Among the four CT scans, one CT scan is a conventional low-dose CT scan (120mA), and the remaining three are extremely low-dose CT scans (10-20mA). The main researchers and nuclear medicine physicians can decide whether to change the subsequent image acquisition time and duration of the subjects based on the image information obtained from the enrolled subjects. | Drug | dose escalation |
Primary outcome
Biological distribution characteristics
Time frame: 1week
Evaluate the biological distribution characteristics of important organs in the subjects. * Draw the Volume of Interest (VOI) of the subject's vital organs and calculate the Percentage of Injected Activity (IA) of the vital organs * Using PMOD software, manually draw regions of interest (VOI) on PET/CT images of the liver, spleen, normal stomach, heart, bone marrow, kidneys, and other areas to obtain the cumulative radioactive activity of these regions. Divide the cumulative radioactive activity by the injection dose to obtain the percentage of injection activity (% IA).
Safety tolerance characteristics
Time frame: hrough study completion, an average of 1 year
AE/SAE/SUSAR
1 secondary outcome
Metabolic Dynamics Evaluation and Radiation Dose
Time frame: 1 day
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 17 Oct 2024.
- Individual participant dataSharing planned: Yes
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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]Ga-NODAGA-SNA014 in people with Adenocarcinoma of the Stomach and Adenocarcinoma of GE Junction, 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: opening soon, as of the sponsor's last update on 17 Oct 2024. 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 Miao liyan Chief Pharmacist, doctorate (0512-679-72858, miaolysuzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological distribution characteristics (time frame: 1week). The study lists 2 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 17 Oct 2024.