NCT02683083已完成1 期
Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients: CAM-VHH1 Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Precirix
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
研究概览
简要总结
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB Anti-HER2 VHH1 in patients with HER2+ breast cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will only be included in the study if they meet all of the following criteria:
- •Subjects who have given informed consent
- •Subjects that agree not to drink alcoholic beverages or use any drugs during the study
- •Subject with blood parameters within normal ranges
- •Age: at least 18 years old
- •Patients will only be included in the study if they meet all of the following criteria:
- •Patients who have given informed consent
- •Patients that agree not to drink alcoholic beverages or use any drugs during the study
- •Age: at least 18 years old
- •Patients with local, locally advanced or metastatic HER2+ breast carcinoma as diagnosed on biopsied tissue by immunohistochemistry or fluorescence in situ hybridization (FISH).
排除标准
- •Patients will not be included in the study if one of the following criteria applies:
- •Pregnant patients
- •Breast feeding patients
- •Patients with occupational exposure to ionizing irradiation
- •Patients with previous thyroid disorders
- •Patients that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.
- •Patients with absolute contra-indications for thyroid blockage with potassium iodide.
- •Patients with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.
- •Patients with abnormal kidney function: < 50 ml/min/1,73 m2
- •Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
- •Patients with any serious active infection
- •Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- •Patients who cannot communicate reliably with the investigator
- •Patients who are unlikely to cooperate with the requirements of the study
- •Patients at increased risk of death from a pre-existing concurrent illness
- •Patients who participated already in this study
- •Patients who participated in a previous trial with Anti-HER2 VHH1
- •Subjects will not be included in the study if one of the following criteria applies:
- •Pregnant subjects
- •Breast feeding subjects
- •Subjects with occupational exposure to ionizing irradiation
- •Subjects with clinical significant disease or on concomitant therapy (except contraception)
- •Subjects with previous thyroid disorders
- •Subjects that received radiolabeled compounds with a long half-life (>7h) for diagnostic or therapeutic purposes within the last 2 days.
- •Subjects with absolute contra-indications for thyroid blockage with potassium iodide.
- •Subjects with abnormal liver: ALT/AST > 2 times normal values; bilirubin > 1.5 time normal values.
- •Subjects with abnormal kidney function: < 50 ml/min/1,73 m2
- •Subjects with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
- •Subjects with any serious active infection
- •Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- •Subjects who cannot communicate reliably with the investigator
- •Subjects who are unlikely to cooperate with the requirements of the study
- •Subjects at increased risk of death from a pre-existing concurrent illness
- •Subjects who participated already in this study
- •Subjects who participated in a previous trial with Anti-HER2 VHH1
研究组 & 干预措施
[131I]-SGMIB Anti-HER2 VHH1
Experimental
干预措施: [131I]-SGMIB Anti-HER2 VHH1 (Biological)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
时间窗: 1 day
次要结局
- The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan(1 day)
研究者
研究点 (2)
Loading locations...
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