Phase I Clinical Trial of 68Ga-NOTA-SNA002

Phase I Clinical Trial of Evaluating 68Ga-NOTA-SNA002 for the Safety Tolerance, Radiation Absorbed Dose and Dosimetry in Patients With Solid Tumor

The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial, 68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation absorption dose, distribution characteristics, etc. in patients with solid tumors.

Study Overview

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

Detailed Description

The study consisted of four phases: screening period , baseline period , trial period and safety follow-up period .

Screening period 2 weeks before the start of the trial, all eligible subjects were selected to participate in the clinical trial. The informed consent signed by the subjects is required before performing all the examinations in this clinical trial.

Baseline period The admission criteria were checked again, and the subjects were enrolled on the same day after the check.

Trial period Including drug administration, blood collection, image collection and pathological tissue collection.

Safe follow-up period All adverse events and drug combinations are processed and recorded during this period.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hongcheng Shi, Doctor; Phone Number: 2470 +86 02164041990; Email: shi.hongcheng@zs-hospital.sh.cn
• Study Contact Backup: Name: Yan Di; Phone Number: +86 051267229125; Email: cm@smartnucl.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital Affiliated to Fudan University
    • Contact: Hongcheng Shi, Docter; Phone Number: 2470 +86 02164041990; Email: shi.hongcheng@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years old (including boundary values);
2. Those who have behavioral capacity, voluntarily participate in this clinical study, and sign an informed consent form (ICF);
3. Physical condition (ECOG) score 0-2 points;
4. Basal heart rate 60~100 beats/min (including the boundary value, which refers to the seated heart rate of the patient in a calm state);
5. Blood pressure measurements < High blood pressure level 1 (includes a history of high blood pressure, systolic blood pressure treated with exercise or medication; 140 and diastolic blood pressure< 90mmHg); Specialty situation
6. Patients with confirmed solid tumors (including but not limited to non-small cell lung cancer, breast cancer, head and neck squamous cell carcinoma, malignant melanoma) with or without metastatic tumors;
7. Patients whose imaging findings indicate that at least one target lesion is measurable and can be biopsied (CT, MRI, or 18F-FDG PET-CT results are acceptable);
8. Pathological findings were obtained within the previous 1 year.

Exclusion Criteria:

1. Patients who are unable to perform visits or undergo relevant examinations, operations or biopsies in accordance with the clinical trial protocol;
2. Poor nutritional status, screening BMI< 18.5, can not tolerate the test;
3. People with known or suspected evidence of active autoimmune disease (e.g., vitiligo, diabetes, residual hypothyroidism due to autoimmune disease requiring hormone replacement therapy only, autoimmunological disease such as psoriasis that does not require systemic treatment), Or diseases that are not expected to recur in the absence of external triggers are allowed to be included in the study);
4. Patients who take large doses of hormones, such as hydrocortisone or 5mg prednisone in the morning and hydrocortisone or 2.5mg prednisone in the evening;
5. Patients with serious diseases or other malignant tumors (except those who have been cured one year ago or do not require additional treatment);
6. People with known severe allergy to 68Ga-NOTA-SNA002, similar drugs or excipients.

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: dose escalation; 4 subgroups mass dose escalation.	Drug: 68Ga-NOTA-SNA002; 68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min.; Other Names: Positron Emission Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of administration(Vital signs)	The safety of administration will be evaluated based on the assessments of blood pressure, heart rate, respiration and body temperature before and after administration(% of cases with abnormal findings relative to baseline).	up to 7 days
Laboratory examination	such as blood routine, blood biochemistry, urine routine, coagulation function, etc., to evaluate the changes of laboratory examination of subjects before and after administration	up to 7 days
Incidence of adverse events	The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of 68Ga-NOTA-SNA002.	through study completion, an average of 1 month
Biological distribution characteristics	Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET	60 minutes ~120 minutes after administration
Anti-SNA002 anti-antibody	By analyzing anti-SNA002 anti-drug antibody positive rate.	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in whole blood and serum radioactive dose	Measurement of 68Ga Radiation exposure in whole blood and serum after administration	60 minutes after Blood sampling
Standardized uptake values based on whole-body PET imaging	Analyzing whole body PET images，Define area of interest (ROI) and/or volume of Interest (VOI), calculate standardized uptake values (SUVmax, SUVmean, etc.)	1 month
Radiation absorbed dose of major organs	Calculation of the radiation dose for each vital organ by means of radiation uptake values	1 month

Collaborators and Investigators

• Sponsor: SmartNuclide Biopharma
• Investigators: Principal Investigator: Hongcheng Shi, Doctor, Department of Nuclear Medicine, Zhongshan Hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

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

More Information

Terms related to this study

• Other Study ID Numbers: SN-SNA002-2023-001

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