drugset / Trial / NCT02683083

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

NCT02683083 ↗

Phase 1 Completed 9 enrolled Precirix
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2016-10
Primary completion
2018-02-05
Completion
2018-02-05

Drugs

EvaluationDrugModalityDoseRoute
Subject [131I]-SGMIB Anti-HER2 VHH1 Unknown — —

Indications