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Trial Title:
[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
NCT ID:
NCT05490264
Condition:
Solid Tumor
Positron-Emission Tomography(PET)
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
[68Ga]Ga-NOTA-SNA002
Description:
[68Ga]Ga-NOTA-SNA002（PD-L1 PET Tracer）for Positron Emission Tomography
Arm group label:
[68Ga]Ga-NOTA-SNA002
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years (including boundary values);
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:
1. Those who are unable to follow this clinical trial protocol well enough to make
visits, or undergo relevant examinations, or treatment;
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Wang, Ph.D
Phone:
(86) 512 67972858
Email:
0814wangyan@163.com
Start date:
October 18, 2022
Completion date:
July 30, 2024
Lead sponsor:
Agency:
SmartNuclide Biopharma
Agency class:
Industry
Collaborator:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
SmartNuclide Biopharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490264
