Solid TumorPhase 1NCT05989997
Phase I Clinical Trial of 68Ga-NOTA-SNA002
A Phase 1 study testing 68Ga-NOTA-SNA002 in people with Solid Tumor and Positron-Emission Tomography(PET), run by SmartNuclide Biopharma at 1 site in China.
Trial summary
The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial, 68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation absorption dose, distribution characteristics, etc. in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Positron-Emission Tomography(PET)
- What is being tested?
- 68Ga-NOTA-SNA002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 8 Nov 2024
- Phase
- 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
- Age 18-75 years old (including boundary values);
- Those who have behavioral capacity, voluntarily participate in this clinical study, and sign an informed consent form (ICF);
- Physical condition (ECOG) score 0-2 points;
- Basal heart rate 60~100 beats/min (including the boundary value, which refers to the seated heart rate of the patient in a calm state);
- Blood pressure measurements < High blood pressure level 1 (includes a history of high blood pressure, systolic blood pressure treated with exercise or medication; 140 and diastolic blood pressure< 90mmHg); Specialty situation
- Patients with confirmed solid tumors (including but not limited to non-small cell lung cancer, breast cancer, head and neck squamous cell carcinoma, malignant melanoma) with or without metastatic tumors;
- Patients whose imaging findings indicate that at least one target lesion is measurable and can be biopsied (CT, MRI, or 18F-FDG PET-CT results are acceptable);
- Pathological findings were obtained within the previous 1 year.
Who cannot join
- Patients who are unable to perform visits or undergo relevant examinations, operations or biopsies in accordance with the clinical trial protocol;
- Poor nutritional status, screening BMI< 18.5, can not tolerate the test;
- People with known or suspected evidence of active autoimmune disease (e.g., vitiligo, diabetes, residual hypothyroidism due to autoimmune disease requiring hormone replacement therapy only, autoimmunological disease such as psoriasis that does not require systemic treatment), Or diseases that are not expected to recur in the absence of external triggers are allowed to be included in the study);
- Patients who take large doses of hormones, such as hydrocortisone or 5mg prednisone in the morning and hydrocortisone or 2.5mg prednisone in the evening;
- Patients with serious diseases or other malignant tumors (except those who have been cured one year ago or do not require additional treatment);
- People with known severe allergy to 68Ga-NOTA-SNA002, similar drugs or excipients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial of Evaluating 68Ga-NOTA-SNA002 for the Safety Tolerance, Radiation Absorbed Dose and Dosimetry in Patients With Solid Tumor
The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial, 68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation absorption dose, distribution characteristics, etc. in patients with solid tumors.
Read the detailed description
The study consisted of four phases: screening period , baseline period , trial period and safety follow-up period .
Screening period 2 weeks before the start of the trial, all eligible subjects were selected to participate in the clinical trial. The informed consent signed by the subjects is required before performing all the examinations in this clinical trial.
Baseline period The admission criteria were checked again, and the subjects were enrolled on the same day after the check.
Trial period Including drug administration, blood collection, image collection and pathological tissue collection.
Safe follow-up period All adverse events and drug combinations are processed and recorded during this period.
- Conditions
- Solid Tumor, Positron-Emission Tomography(PET)
- Being tested
- 68Ga-NOTA-SNA002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-SNA002Drug
Also called Positron Emission Tomography
68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | 4 subgroups mass dose escalation. Receives: Drug: 68Ga-NOTA-SNA002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of administration(Vital signs)
The safety of administration will be evaluated based on the assessments of blood pressure, heart rate, respiration and body temperature before and after administration(% of cases with abnormal findings relative to baseline).
Measured: up to 7 days
Laboratory examination
such as blood routine, blood biochemistry, urine routine, coagulation function, etc., to evaluate the changes of laboratory examination of subjects before and after administration
Measured: up to 7 days
Incidence of adverse events
The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of 68Ga-NOTA-SNA002.
Measured: through study completion, an average of 1 month
Biological distribution characteristics
Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET
Measured: 60 minutes ~120 minutes after administration
Anti-SNA002 anti-antibody
By analyzing anti-SNA002 anti-drug antibody positive rate.
Measured: up to 1 month
Secondary outcomes (3)
Changes in whole blood and serum radioactive dose
Measurement of 68Ga Radiation exposure in whole blood and serum after administration
Measured: 60 minutes after Blood sampling
Standardized uptake values based on whole-body PET imaging
Analyzing whole body PET images，Define area of interest (ROI) and/or volume of Interest (VOI), calculate standardized uptake values (SUVmax, SUVmean, etc.)
Measured: 1 month
Radiation absorbed dose of major organs
Calculation of the radiation dose for each vital organ by means of radiation uptake values
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Nov 2023
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- SmartNuclide Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongcheng Shi, Doctor, Principal investigator, Department of Nuclear Medicine, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989997
- Sponsor's protocol ID
- SN-SNA002-2023-001
- Status last verified
- Sep 2025
- First submitted
- 27 Jul 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Evaluating 68Ga-NOTA-SNA002 for the Safety Tolerance, Radiation Absorbed Dose and Dosimetry in Patients With Solid Tumor
- ClinicalTrials.gov ID
- NCT05989997
- Acronym / sponsor ID
- SN-SNA002-2023-001
- Conditions
- Solid Tumor, Positron-Emission Tomography(PET)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- SmartNuclide BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 14 Aug 2023 (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.
The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial, 68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation absorption dose, distribution characteristics, etc. in patients with solid tumors.
Detailed description
The study consisted of four phases: screening period , baseline period , trial period and safety follow-up period .
Screening period 2 weeks before the start of the trial, all eligible subjects were selected to participate in the clinical trial. The informed consent signed by the subjects is required before performing all the examinations in this clinical trial.
Baseline period The admission criteria were checked again, and the subjects were enrolled on the same day after the check.
Trial period Including drug administration, blood collection, image collection and pathological tissue collection.
Safe follow-up period All adverse events and drug combinations are processed and recorded during this period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation | Experimental | Drug: 68Ga-NOTA-SNA0024 subgroups mass dose escalation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years old (including boundary values);
- Those who have behavioral capacity, voluntarily participate in this clinical study, and sign an informed consent form (ICF);
- Physical condition (ECOG) score 0-2 points;
- Basal heart rate 60~100 beats/min (including the boundary value, which refers to the seated heart rate of the patient in a calm state);
- Blood pressure measurements < High blood pressure level 1 (includes a history of high blood pressure, systolic blood pressure treated with exercise or medication; 140 and diastolic blood pressure< 90mmHg); Specialty situation
Key exclusion criteria (6 listed)
- Patients who are unable to perform visits or undergo relevant examinations, operations or biopsies in accordance with the clinical trial protocol;
- Poor nutritional status, screening BMI< 18.5, can not tolerate the test;
- People with known or suspected evidence of active autoimmune disease (e.g., vitiligo, diabetes, residual hypothyroidism due to autoimmune disease requiring hormone replacement therapy only, autoimmunological disease such as psoriasis that does not require systemic treatment), Or diseases that are not expected to recur in the absence of external triggers are allowed to be included in the study);
- Patients who take large doses of hormones, such as hydrocortisone or 5mg prednisone in the morning and hydrocortisone or 2.5mg prednisone in the evening;
- Patients with serious diseases or other malignant tumors (except those who have been cured one year ago or do not require additional treatment);
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-NOTA-SNA002Also: Positron Emission Tomography68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min. | Drug | dose escalation |
Primary outcome
Safety of administration(Vital signs)
Time frame: up to 7 days
The safety of administration will be evaluated based on the assessments of blood pressure, heart rate, respiration and body temperature before and after administration(% of cases with abnormal findings relative to baseline).
Laboratory examination
Time frame: up to 7 days
such as blood routine, blood biochemistry, urine routine, coagulation function, etc., to evaluate the changes of laboratory examination of subjects before and after administration
Incidence of adverse events
Time frame: through study completion, an average of 1 month
The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of 68Ga-NOTA-SNA002.
Biological distribution characteristics
Time frame: 60 minutes ~120 minutes after administration
Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET
Anti-SNA002 anti-antibody
Time frame: up to 1 month
By analyzing anti-SNA002 anti-drug antibody positive rate.
3 secondary outcomes
Changes in whole blood and serum radioactive dose
Time frame: 60 minutes after Blood sampling
Standardized uptake values based on whole-body PET imaging
Time frame: 1 month
Radiation absorbed dose of major organs
Time frame: 1 month
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 16 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Hongcheng Shi, Doctor principal investigator
Department of Nuclear Medicine, Zhongshan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-NOTA-SNA002 in people with Solid Tumor and Positron-Emission Tomography(PET), 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 8 inclusion and 6 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 16 Sep 2025. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of administration(Vital signs) (time frame: up to 7 days). The study lists 5 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 16 Sep 2025.