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

NCT05490264 | Unknown Early Phase 1

• 1 other identifier: SN-2022-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Positron-Emission Tomography(PET)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Standard Uptake Value(max) in tumors

  12 months

• Standard Uptake Value(peak) in tumors

  12 months

• Standard Uptake Value(mean) in tumors

  12 months

• Correlation of [68Ga]Ga-NOTA-SNA002 uptake in biopsied tumors with PD-L1 measurement by immunohistochemistry (IHC)

  12 months

Study Arms (1)

[68Ga]Ga-NOTA-SNA002

EXPERIMENTAL

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

Interventions

[68Ga]Ga-NOTA-SNA002 BIOLOGICAL

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

[68Ga]Ga-NOTA-SNA002

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years (including boundary values);
• Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
• Performance status (ECOG) score 0-2 points (see Appendix 1 for details);
• Basal heart rate 60-100 beats/min (including boundary values);
• 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);
• Patients with confirmed solid tumors;
• Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
• 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);
• Patients obtained with immunohistochemical PD-L1 expression results within the previous month.

You may not qualify if:

• Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment;
• Those who have extremely poor nutritional status and cannot tolerate the trial;
• Known or suspected evidence of active autoimmune disease;
• 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；
• Those with known severe allergy to SNA002, similar drugs or excipients；
• Patients with brain metastases；
• 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；
• Women who are pregnant or breastfeeding.
• Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.

Sponsors & Collaborators

• SmartNuclide Biopharma: lead
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Study Officials

• Liyan Miao, Ph.D

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

• Songbing Qin

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zhang

CONTACT

(86) 0512 67972858; sdfyy8040@126.com

Yan Wang, Ph.D

CONTACT

(86) 0512 67972858; 0814wangyan@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: August 5, 2022
• Study Start: October 18, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)