Phase I Clinical Trial of Evaluating 68Ga-NOTA-SNA002 for the Safety Tolerance, Radiation Absorbed Dose and Dosimetry in Patients With Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Laboratory examination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
dose escalation
4 subgroups mass dose escalation.
干预措施: 68Ga-NOTA-SNA002 (Drug)
结局指标
主要结局
Laboratory examination
时间窗: 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
时间窗: 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.
Safety of administration(Vital signs)
时间窗: 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).
Biological distribution characteristics
时间窗: 60 minutes ~120 minutes after administration
Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET
Anti-SNA002 anti-antibody
时间窗: up to 1 month
By analyzing anti-SNA002 anti-drug antibody positive rate.
次要结局
- Standardized uptake values based on whole-body PET imaging(1 month)
- Changes in whole blood and serum radioactive dose(60 minutes after Blood sampling)
- Radiation absorbed dose of major organs(1 month)