Solid TumorEarly Phase 1NCT05126927

A PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors

A Early Phase 1 study testing 68Ga-NODAGA-SNA006 in people with Solid Tumor, run by SmartNuclide Biopharma at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Solid Tumor
What is being tested?: 68Ga-NODAGA-SNA006
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteChina
Study dates: 2 Nov 2021to 1 Aug 2022
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-70 years (including boundary values);
Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
Performance status (ECOG) score 0-1 points (see Appendix 1 for details);
Basal heart rate 60-100 beats/min (including boundary values);
Blood pressure measurement < hypertension grade 1 level (including a history of hypertension, systolic blood pressure < 140 and diastolic blood pressure < 90 mmHg by exercise or drug treatment);
Patients with confirmed solid tumors;

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Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FDG PET/CT results are acceptable);
Patients with immunohistochemical CD8 results within the past month;

Who cannot join

Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment.
Those who have extremely poor nutritional status and cannot tolerate the trial
Those with comorbid major diseases or other malignancies (except those that have healed by one year or do not require additional treatment)
Those with known severe allergy to SNA006, similar drugs or excipients. Specialized conditions
Patients who have undergone previous splenectomy or splenic disease such as hypersplenism or splenomegaly
Patients with brain metastases.

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Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies
Patients who have not recovered from a serious infection
Patients with drug/alcohol abuse, severe mental disorders
Those with claustrophobia, emotional instability, acute persistent spasticity or inability to keep both arms up and lying flat for 15-30 minutes
Those who have participated in any other clinical trial within 3 months prior to screening
Women who are pregnant or breastfeeding.
Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu

Other trials in China

About this study

Official title: A Study to Evaluate the Safety Tolerability, Radiation Absorbed Dose,Distribution, PET Imaging and Histological Expression of 68GA-Nodaga-SNA006 in Patients With Solid Tumors.

Primary objective To investigate the safety and tolerability profile of 68Ga- NODAGA-SNA006 in patients with solid tumors; To investigate the radiation absorbed dose characteristics of 68Ga-NODAGA-SNA006 in patients with solid tumors; To investigate the distribution profile of 68Ga-NODAGA-SNA006 in patients with solid tumors. Secondary objectives To investigate the optimal administration dose and radiation safety profile of 68Ga-NODAGA-SNA006; To investigate the PET imaging characteristics and high-quality imaging time window of 68Ga-NODAGA-SNA006 in patients with solid tumors; To explore the correlation between PET imaging characteristics of 68Ga-NODAGA-SNA006 binding to CD8 and histological CD8 expression characteristics; To explore peripheral blood T lymphocyte differentiation (CD8, CD4, CD3, etc.) in patients with solid tumors.

Read the detailed description

The study had a dose-escalation, open-label design. Intravenous injection of SNA006 was used to observe its safety tolerance, radiation absorbed dose, distribution, and PET imaging characteristics in patients with solid tumors. The study consists of three phases, namely, a screening period, a trial period, and a safety follow-up period.

Safety evaluation Observe any AE occurred in all subjects during the clinical study, record the clinical features, severity, occurrence time, end time, duration, treatment measures and outcome, and determine the correlation between any AE and the study drug.
efficacy evaluation 2.1. Evaluation of imaging characteristics In this clinical trial, PET imaging characteristics will be evaluated by an independent imaging evaluation committee, and the PET imaging operating procedures and parameters will be detailed in the PET/CT standard operating procedures. 2.2. Evaluation of correlation between imaging expression and immunohistochemistry.

Conditions: Solid Tumor
Being tested: 68Ga-NODAGA-SNA006

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

68Ga-NODAGA-SNA006Biological
A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors

Study groups in NCT05126927
Study group	Role	What they receive
68Ga-NODAGA-SNA006	Experimental	A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors Receives: Biological: 68Ga-NODAGA-SNA006

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety evaluation indicators
AE/SAE/SUSAR. To observe AE/SAE/SUSAR of subjects during trial period, until 12 months after trial finished.
Measured: 12 months

Secondary outcomes (3)

Immunogenicity evaluation
ADA blood samples were collected twice, and tested in an independent third party central laboratory. Then, ADA positive rate were analysied.
Measured: 1 week
Evaluation of imaging characteristics
Target/background ratio in PET imaging of tumor lesions was calculated, compared target lesions with contralateral lesions, liver and muscle.
Measured: 12 months
Evaluation of the correlation between imaging expression and immunohistochemistry
Immunohistochemical analysis (third-party independent central laboratory testing) was performed on the collected tumor tissue samples, and the scoring results were compared with the imaging expression results to calculate the sensitivity, specificity and other results.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 20211 Aug 2022

First posted19 Nov 2021
Study start2 Nov 2021
Primary completion19 Jan 2022
Study completion1 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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: Early Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05126927
Sponsor's protocol ID: SN-2021-01
Status last verified: Apr 2023
First submitted: 1 Nov 2021
Last updated: 12 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wang Y, Zheng M, Zhao J, Wang C, Zhao S, Bian Y, Dai N, Zheng Y, Sang S, Guo L, Huang C, Zhang H, Jiang J, Xu C, Zhao Q, Han J, Xu T, Qin S, Miao L. Human dose-escalation study of PET imaging CD8+ T-cell infiltration in solid malignancies with [68Ga]Ga -NODAGA-SNA006. Eur J Nucl Med Mol Imaging. 2025 Mar;52(4):1332-1344. doi: 10.1007/s00259-024-06999-x. Epub 2024 Dec 10.
PubMed 39653817
Wang Y, Wang C, Huang M, Qin S, Zhao J, Sang S, Zheng M, Bian Y, Huang C, Zhang H, Guo L, Jiang J, Xu C, Dai N, Zheng Y, Han J, Yang M, Xu T, Miao L. Pilot study of a novel nanobody 68 Ga-NODAGA-SNA006 for instant PET imaging of CD8+ T cells. Eur J Nucl Med Mol Imaging. 2022 Nov;49(13):4394-4405. doi: 10.1007/s00259-022-05903-9. Epub 2022 Jul 13.
PubMed 35829748

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety Tolerability, Radiation Absorbed Dose,Distribution, PET Imaging and Histological Expression of 68GA-Nodaga-SNA006 in Patients With Solid Tumors.
ClinicalTrials.gov ID: NCT05126927
Acronym / sponsor ID: SN-2021-01
Conditions: Solid Tumor
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: SmartNuclide BiopharmaIndustry (pharma, biotech, devices)
Collaborators: The First Affiliated Hospital of Soochow University
Study start: 2 Nov 2021 (actual)
Primary completion: 19 Jan 2022 (actual)
Study completion: 1 Aug 2022 (actual)
First posted: 19 Nov 2021 (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.

Detailed description

Safety evaluation Observe any AE occurred in all subjects during the clinical study, record the clinical features, severity, occurrence time, end time, duration, treatment measures and outcome, and determine the correlation between any AE and the study drug.
efficacy evaluation 2.1. Evaluation of imaging characteristics In this clinical trial, PET imaging characteristics will be evaluated by an independent imaging evaluation committee, and the PET imaging operating procedures and parameters will be detailed in the PET/CT standard operating procedures. 2.2. Evaluation of correlation between imaging expression and immunohistochemistry.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
68Ga-NODAGA-SNA006	Experimental	Biological: 68Ga-NODAGA-SNA006A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age 18-70 years (including boundary values);
Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
Performance status (ECOG) score 0-1 points (see Appendix 1 for details);
Basal heart rate 60-100 beats/min (including boundary values);
Blood pressure measurement < hypertension grade 1 level (including a history of hypertension, systolic blood pressure < 140 and diastolic blood pressure < 90 mmHg by exercise or drug treatment);

Key exclusion criteria (13 listed)

Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment.
Those who have extremely poor nutritional status and cannot tolerate the trial
Those with comorbid major diseases or other malignancies (except those that have healed by one year or do not require additional treatment)
Those with known severe allergy to SNA006, similar drugs or excipients. Specialized conditions
Patients who have undergone previous splenectomy or splenic disease such as hypersplenism or splenomegaly

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-SNA006A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors	Biological	68Ga-NODAGA-SNA006

Primary outcome

Safety evaluation indicators
Time frame: 12 months
AE/SAE/SUSAR. To observe AE/SAE/SUSAR of subjects during trial period, until 12 months after trial finished.

3 secondary outcomes

Immunogenicity evaluation
Time frame: 1 week
Evaluation of imaging characteristics
Time frame: 12 months
Evaluation of the correlation between imaging expression and immunohistochemistry
Time frame: 12 months

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 12 Apr 2023.
Derived from this study: PubMed 39653817Wang Y, Zheng M, Zhao J, Wang C, Zhao S, Bian Y, Dai N, Zheng Y, Sang S, Guo L, Huang C, Zhang H, Jiang J, Xu C, Zhao Q, Han J, Xu T, Qin S, Miao L. Human dose-escalation study of PET imaging CD8+ T-cell infiltration in solid malignancies with [68Ga]Ga -NODAGA-SNA006. Eur J Nucl Med Mol Imaging. 2025 Mar;52(4):1332-1344. doi: 10.1007/s00259-024-06999-x. Epub 2024 Dec 10.
Derived from this study: PubMed 35829748Wang Y, Wang C, Huang M, Qin S, Zhao J, Sang S, Zheng M, Bian Y, Huang C, Zhang H, Guo L, Jiang J, Xu C, Dai N, Zheng Y, Han J, Yang M, Xu T, Miao L. Pilot study of a novel nanobody 68 Ga-NODAGA-SNA006 for instant PET imaging of CD8+ T cells. Eur J Nucl Med Mol Imaging. 2022 Nov;49(13):4394-4405. doi: 10.1007/s00259-022-05903-9. Epub 2022 Jul 13.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Liyan Miao, Ph.D principal investigator

The First Affiliated Hospital of Soochow University

Songbing Qin principal investigator

The First Affiliated Hospital of Soochow University

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 Solid Tumor, 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 9 inclusion and 13 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 12 Apr 2023. 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?

Safety evaluation indicators (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05126927, which also lists 2 linked publications.

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 12 Apr 2023.