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

Precirix1 site in 1 country9 target enrollmentOctober 2016

ConditionsHealthy Volunteers Breast Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: Precirix
Enrollment: 9
Locations: 1
Primary Endpoint: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

February 5, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Precirix

Responsible Party

Sponsor

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