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

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
[131I]-SGMIB Anti-HER2 VHH1	[131I]-SGMIB Anti-HER2 VHH1	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	1 day

Secondary Outcome Measures

Name	Time	Method
The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan	1 day	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.