Clinical trial NCT05490264: [68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
Official title: [68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Solid Tumor
Positron-Emission Tomography(PET)
Lead sponsor: SmartNuclide Biopharma
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2022-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Time of infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) through Visit（Day 6）
measure: Changes of vital signs in participants compared with baseline results.
timeFrame: Baseline and 6 hours after infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) and 2 hours after tumor biopsy(Day 2)
measure: Changes in laboratory values compared with baseline results.
timeFrame: Baseline and Visit（Day 6）
measure: Immunogenicity Analysis of [68Ga]Ga-NOTA-SNA002
timeFrame: 1 month
measure: Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET
timeFrame: 1 month
Secondary outcomes:
measure: Standard Uptake Value(max) in tumors
timeFrame: 12 months
measure: Standard Uptake Value(peak) in tumors
timeFrame: 12 months
measure: Standard Uptake Value(mean) in tumors
timeFrame: 12 months
measure: Correlation of [68Ga]Ga-NOTA-SNA002 uptake in biopsied tumors with PD-L1 measurement by immunohistochemistry (IHC)
timeFrame: 12 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Liyan Miao, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Soochow University
name: Songbing Qin
role: PRINCIPAL_INVESTIGATOR
References: