[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors

Solid Tumor Clinical Trial

Official title:

[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490264
• Other study ID #: SN-2022-01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 18, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: December 2023
• Source: SmartNuclide Biopharma
• Contact: Hua Zhang
• Phone: (86) 0512 67972858
• Email: sdfyy8040[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• [68Ga]Ga-NOTA-SNA002
[68Ga]Ga-NOTA-SNA002(PD-L1 PET Tracer)for Positron Emission Tomography

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
SmartNuclide Biopharma	The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Immunogenicity Analysis of [68Ga]Ga-NOTA-SNA002	By analyzing anti-SNA002 anti-drug antibody positive rate.	1 month
Primary	Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET	Description of biodistribution patterns of [68Ga]Ga-NOTA-SNA002 on PET.	1 month
Secondary	Standard Uptake Value(max) in tumors	SUVmax quantitative analysis in tumors	12 months
Secondary	Standard Uptake Value(peak) in tumors	SUVpeak quantitative analysis in tumors	12 months
Secondary	Standard Uptake Value(mean) in tumors	SUVmean quantitative analysis in tumors	12 months
Secondary	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