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| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga-NOTA-SNA002 | Biological | [68Ga]Ga-NOTA-SNA002(PD-L1 PET Tracer)for Positron Emission Tomography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | Baseline and Visit(Day 6) |
| Immunogenicity Analysis of [68Ga]Ga-NOTA-SNA002 | By analyzing anti-SNA002 anti-drug antibody positive rate. | 1 month |
| Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET | Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Uptake Value(max) in tumors | SUVmax quantitative analysis in tumors | 12 months |
| Standard Uptake Value(peak) in tumors | SUVpeak quantitative analysis in tumors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Zhang | Contact | (86) 0512 67972858 | sdfyy8040@126.com | |
| Yan Wang, Ph.D | Contact | (86) 0512 67972858 | 0814wangyan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, Ph.D | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Songbing Qin | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
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| 12 months |
| Standard Uptake Value(mean) in tumors | SUVmean quantitative analysis in tumors | 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. | 12 months |