Clinical trial NCT05989997: Phase I Clinical Trial of 68Ga-NOTA-SNA002
Official title: Phase I Clinical Trial of Evaluating 68Ga-NOTA-SNA002 for the Safety Tolerance, Radiation Absorbed Dose and Dosimetry in Patients With Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Positron-Emission Tomography(PET)
Lead sponsor: SmartNuclide Biopharma
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Safety of administration(Vital signs)
timeFrame: up to 7 days
measure: Laboratory examination
timeFrame: up to 7 days
measure: Incidence of adverse events
timeFrame: through study completion, an average of 1 month
measure: Biological distribution characteristics
timeFrame: 60 minutes ~120 minutes after administration
measure: Anti-SNA002 anti-antibody
timeFrame: up to 1 month
Secondary outcomes:
measure: Changes in whole blood and serum radioactive dose
timeFrame: 60 minutes after Blood sampling
measure: Standardized uptake values based on whole-body PET imaging
timeFrame: 1 month
measure: Radiation absorbed dose of major organs
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
Study officials:
affiliation: Department of Nuclear Medicine, Zhongshan Hospital, Fudan University
name: Hongcheng Shi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: