Phase I Clinical Trial of 68Ga-NOTA-SNA002

NCT05989997 | Completed Phase 1 FDA Drug

• 1 other identifier: SN-SNA002-2023-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Positron-Emission Tomography(PET)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Changes in whole blood and serum radioactive dose

  60 minutes after Blood sampling

• Standardized uptake values based on whole-body PET imaging

  1 month

• Radiation absorbed dose of major organs

  1 month

Study Arms (1)

dose escalation

EXPERIMENTAL

4 subgroups mass dose escalation.

Drug: 68Ga-NOTA-SNA002

Interventions

68Ga-NOTA-SNA002 DRUG

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

Also known as: Positron Emission Tomography

dose escalation

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 old (including boundary values);
• Those who have behavioral capacity, voluntarily participate in this clinical study, and sign an informed consent form (ICF);
• Physical condition (ECOG) score 0-2 points;
• 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);
• 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
• 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;
• 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);
• Pathological findings were obtained within the previous 1 year.

You may not qualify if:

• Patients who are unable to perform visits or undergo relevant examinations, operations or biopsies in accordance with the clinical trial protocol;
• Poor nutritional status, screening BMI\< 18.5, can not tolerate the test;
• 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);
• 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;
• Patients with serious diseases or other malignant tumors (except those who have been cured one year ago or do not require additional treatment);
• People with known severe allergy to 68Ga-NOTA-SNA002, similar drugs or excipients.

Sponsors & Collaborators

• SmartNuclide Biopharma: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Hongcheng Shi, Doctor

  Department of Nuclear Medicine, Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)