[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
NCT ID: NCT05490264
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2022-10-18
2024-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[68Ga]Ga-NOTA-SNA002
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
[68Ga]Ga-NOTA-SNA002
\[68Ga\]Ga-NOTA-SNA002（PD-L1 PET Tracer）for Positron Emission Tomography
Interventions
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[68Ga]Ga-NOTA-SNA002
\[68Ga\]Ga-NOTA-SNA002（PD-L1 PET Tracer）for Positron Emission Tomography
Eligibility Criteria
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Inclusion Criteria
2. Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
3. Performance status (ECOG) score 0-2 points (see Appendix 1 for details);
4. Basal heart rate 60-100 beats/min (including boundary values);
5. 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);
6. Patients with confirmed solid tumors;
7. Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
8. 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);
9. Patients obtained with immunohistochemical PD-L1 expression results within the previous month.
Exclusion Criteria
2. Those who have extremely poor nutritional status and cannot tolerate the trial;
3. Known or suspected evidence of active autoimmune disease;
4. 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；
5. Those with known severe allergy to SNA002, similar drugs or excipients；
6. Patients with brain metastases；
7. 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；
8. Women who are pregnant or breastfeeding.
9. Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
SmartNuclide Biopharma
INDUSTRY
Responsible Party
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Principal Investigators
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Liyan Miao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Songbing Qin
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Yan Wang, Ph.D
Role: primary
Other Identifiers
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SN-2022-01
Identifier Type: -
Identifier Source: org_study_id