Phase I Clinical Trial of 68Ga-NOTA-SNA002
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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 Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Safety of administration(Vital signs) [up to 7 days]
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).
- Laboratory examination [up to 7 days]
such as blood routine, blood biochemistry, urine routine, coagulation function, etc., to evaluate the changes of laboratory examination of subjects before and after administration
- Incidence of adverse events [through study completion, an average of 1 month]
The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of 68Ga-NOTA-SNA002.
- Biological distribution characteristics [60 minutes ~120 minutes after administration]
Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET
- Anti-SNA002 anti-antibody [up to 1 month]
By analyzing anti-SNA002 anti-drug antibody positive rate.
Secondary Outcome Measures
- Changes in whole blood and serum radioactive dose [60 minutes after Blood sampling]
Measurement of 68Ga Radiation exposure in whole blood and serum after administration
- Standardized uptake values based on whole-body PET imaging [1 month]
Analyzing whole body PET images，Define area of interest (ROI) and/or volume of Interest (VOI), calculate standardized uptake values (SUVmax, SUVmean, etc.)
- Radiation absorbed dose of major organs [1 month]
Calculation of the radiation dose for each vital organ by means of radiation uptake values
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-75 years old (including boundary values);
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Those who have behavioral capacity, voluntarily participate in this clinical study, and sign an informed consent form (ICF);
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Physical condition (ECOG) score 0-2 points;
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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);
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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
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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;
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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);
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Pathological findings were obtained within the previous 1 year.
Exclusion Criteria:
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Patients who are unable to perform visits or undergo relevant examinations, operations or biopsies in accordance with the clinical trial protocol;
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Poor nutritional status, screening BMI< 18.5, can not tolerate the test;
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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);
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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;
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Patients with serious diseases or other malignant tumors (except those who have been cured one year ago or do not require additional treatment);
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People with known severe allergy to 68Ga-NOTA-SNA002, similar drugs or excipients.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital Affiliated to Fudan University | Shanghai | China |
Sponsors and Collaborators
- SmartNuclide Biopharma
Investigators
- Principal Investigator: Hongcheng Shi, Doctor, Department of Nuclear Medicine, Zhongshan Hospital, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SN-SNA002-2023-001