Phase I Clinical Trial of 68Ga-NOTA-SNA002

NCT ID: NCT05989997

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-11-08

Brief Summary

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.

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.

Conditions

Solid Tumor; Positron-Emission Tomography(PET)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

dose escalation

4 subgroups mass dose escalation.

Group Type: EXPERIMENTAL

68Ga-NOTA-SNA002

Intervention Type: DRUG

68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min.

Interventions

68Ga-NOTA-SNA002

68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min.

Intervention Type: DRUG

Other Intervention Names

Positron Emission Tomography

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SmartNuclide Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongcheng Shi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Nuclear Medicine, Zhongshan Hospital, Fudan University

Locations

Zhongshan Hospital Affiliated to Fudan University

Shanghai, , China

Countries

China

Other Identifiers

SN-SNA002-2023-001

Identifier Type: -

Identifier Source: org_study_id