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
Condition: Healthy Volunteers; Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: [131I]-SGMIB Anti-HER2 VHH1
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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