Solid TumorEarly Phase 1NCT05490264
[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
A Early Phase 1 study testing [68Ga]Ga-NOTA-SNA002 in people with Solid Tumor and Positron-Emission Tomography(PET), run by SmartNuclide Biopharma at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of [68Ga]Ga-NOTA-SNA002 and investigate the uptake of [68Ga]Ga-NOTA-SNA002 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]Ga-NOTA-SNA002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2022to 30 Jul 2024
- 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
- Age 18-75 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 0-2 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;
Show all 9Show fewer
- 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-FluroDeoxyGlucose(FDG) PET/CT results are acceptable);
- Patients obtained with immunohistochemical PD-L1 expression results within the previous 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;
- Known or suspected evidence of active autoimmune disease;
- Patients taking high doses of hormones, such as more than 20mg of hydrocortisone or 5mg of prednisone in the morning and more than 10mg of hydrocortisone or 2.5mg of prednisone at night；
- Those with known severe allergy to SNA002, similar drugs or excipients；
- Patients with brain metastases；
Show all 9Show fewer
- 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；
- 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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Yan Wang, Ph.D, (86) 512 67972858, 0814wangyan@163.com
About this study
The purpose of this study is to evaluate the safety of [68Ga]Ga-NOTA-SNA002 and investigate the uptake of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of [68Ga]Ga-NOTA-SNA002 (1.0-5.0mCi) in Day1 and will undergo PET/CT scanning to determine uptake of [68Ga]Ga-NOTA-SNA002 in tumor lesions and reference tissues.
- Conditions
- Solid Tumor, Positron-Emission Tomography(PET)
- Being tested
- [68Ga]Ga-NOTA-SNA002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-NOTA-SNA002Biological
[68Ga]Ga-NOTA-SNA002（PD-L1 PET Tracer）for Positron Emission Tomography
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-NOTA-SNA002 | Experimental | A dose of 1mCi-5mCi of [68Ga]Ga-NOTA-SNA002 between 0.1mg to 0.9mg will be administered intravenously over 5minutes in Day 1 of subject enrollment Receives: Biological: [68Ga]Ga-NOTA-SNA002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of [68Ga]Ga-NOTA-SNA002.
Measured: Time of infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) through Visit（Day 6）
Changes of vital signs in participants compared with baseline results.
Number of participants in CTCAE 5.0 Stage 1 or higher with vital signs after administration
Measured: Baseline and 6 hours after infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) and 2 hours after tumor biopsy(Day 2)
Changes in laboratory values compared with baseline results.
Number of participants in CTCAE 5.0 Stage 1 or higher with laboratory examination(e.g. WBC, RBC, HB and other laboratory tests) after administration.
Measured: Baseline and Visit（Day 6）
Immunogenicity Analysis of [68Ga]Ga-NOTA-SNA002
By analyzing anti-SNA002 anti-drug antibody positive rate.
Measured: 1 month
Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET
Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET.
Measured: 1 month
Secondary outcomes (4)
Standard Uptake Value(max) in tumors
SUVmax quantitative analysis in tumors
Measured: 12 months
Standard Uptake Value(peak) in tumors
SUVpeak quantitative analysis in tumors
Measured: 12 months
Standard Uptake Value(mean) in tumors
SUVmean quantitative analysis in tumors
Measured: 12 months
Correlation of [68Ga]Ga-NOTA-SNA002 uptake in biopsied tumors with PD-L1 measurement by immunohistochemistry (IHC)
Analyze [68Ga]Ga-NOTA-SNA002 uptake in biopsied tumors as determined by SUV-based quantitative measures (SUVmax, SUVpeak, SUVmean) with PD-L1 measurement determined by IHC from biopsy samples.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start18 Oct 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SmartNuclide Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, Ph.D, Principal investigator, The First Affiliated Hospital of Soochow UniversitySongbing Qin, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490264
- Sponsor's protocol ID
- SN-2022-01
- Status last verified
- Dec 2023
- First submitted
- 8 Jul 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT05490264
- Acronym / sponsor ID
- SN-2022-01
- Conditions
- Solid Tumor, Positron-Emission Tomography(PET)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SmartNuclide BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 5 Aug 2022 (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 purpose of this study is to evaluate the safety of [68Ga]Ga-NOTA-SNA002 and investigate the uptake of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of [68Ga]Ga-NOTA-SNA002 (1.0-5.0mCi) in Day1 and will undergo PET/CT scanning to determine uptake of [68Ga]Ga-NOTA-SNA002 in tumor lesions and reference tissues.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-NOTA-SNA002 | Experimental | Biological: [68Ga]Ga-NOTA-SNA002A dose of 1mCi-5mCi of [68Ga]Ga-NOTA-SNA002 between 0.1mg to 0.9mg will be administered intravenously over 5minutes in Day 1 of subject enrollment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 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 0-2 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 (9 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;
- Known or suspected evidence of active autoimmune disease;
- Patients taking high doses of hormones, such as more than 20mg of hydrocortisone or 5mg of prednisone in the morning and more than 10mg of hydrocortisone or 2.5mg of prednisone at night；
- Those with known severe allergy to SNA002, similar drugs or excipients；
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-NOTA-SNA002[68Ga]Ga-NOTA-SNA002（PD-L1 PET Tracer）for Positron Emission Tomography | Biological | [68Ga]Ga-NOTA-SNA002 |
Primary outcome
Incidence of adverse events
Time frame: Time of infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) through Visit（Day 6）
The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of [68Ga]Ga-NOTA-SNA002.
Changes of vital signs in participants compared with baseline results.
Time frame: Baseline and 6 hours after infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) and 2 hours after tumor biopsy(Day 2)
Number of participants in CTCAE 5.0 Stage 1 or higher with vital signs after administration
Changes in laboratory values compared with baseline results.
Time frame: Baseline and Visit（Day 6）
Number of participants in CTCAE 5.0 Stage 1 or higher with laboratory examination(e.g. WBC, RBC, HB and other laboratory tests) after administration.
Immunogenicity Analysis of [68Ga]Ga-NOTA-SNA002
Time frame: 1 month
By analyzing anti-SNA002 anti-drug antibody positive rate.
Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET
Time frame: 1 month
Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET.
4 secondary outcomes
Standard Uptake Value(max) in tumors
Time frame: 12 months
Standard Uptake Value(peak) in tumors
Time frame: 12 months
Standard Uptake Value(mean) in tumors
Time frame: 12 months
Correlation of [68Ga]Ga-NOTA-SNA002 uptake in biopsied tumors with PD-L1 measurement by immunohistochemistry (IHC)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- 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]Ga-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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Zhang ((86) 0512 67972858, sdfyy8040@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Time of infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) through Visit（Day 6）). 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 7 Dec 2023.