Phase I Clinical Trial of 68Ga-NOTA-SNA002

SmartNuclide Biopharma

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Positron-Emission Tomography(PET)

Treatments: Drug: 68Ga-NOTA-SNA002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05989997

SN-SNA002-2023-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

dose escalation

Experimental group

Description:

4 subgroups mass dose escalation.

Treatment:

Drug: 68Ga-NOTA-SNA002