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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers, Breast Cancer

Intervention / Treatment
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* Biological: [131I]-SGMIB Anti-HER2 VHH1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [131I]-SGMIB Anti-HER2 VHH1<br> | Biological: [131I]-SGMIB Anti-HER2 VHH1<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan | Cancer lesions above 3 cm will be visually interpreted by an experienced nuclear medicine physician. Lesions will be scored positive if CAM-H2 uptake in the lesion is higher than surrounding background. | 1 day |