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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Positron-Emission Tomography(PET)
• Intervention / Treatment: Biological: [68Ga]Ga-NOTA-SNA002

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Hua Zhang; Phone Number: (86) 0512 67972858; Email: sdfyy8040@126.com
• Study Contact Backup: Name: Yan Wang, Ph.D; Phone Number: (86) 0512 67972858; Email: 0814wangyan@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • the First Affiliated Hospital of Soochow University
      • Contact: Yan Wang, Ph.D; Phone Number: (86) 512 67972858; Email: 0814wangyan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [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	Biological: [68Ga]Ga-NOTA-SNA002; [68Ga]Ga-NOTA-SNA002（PD-L1 PET Tracer）for Positron Emission Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: SmartNuclide Biopharma
• Collaborators: The First Affiliated Hospital of Soochow University
• Investigators: Principal Investigator: Liyan Miao, Ph.D, the First Affiliated Hospital of Soochow University; Principal Investigator: Songbing Qin, the First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SN-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No