Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast Cancer

Summary

The study described in this protocol is a Phase 1, single center clinical trial to evaluate the safety and potential of \[18F\]GEH121224 as a PET radiotracer for the diagnostic imaging of HER2 positive breast cancer lesions. A group of 6 patients will be selected to perform a dosimetry study with \[18F\]GEH121224 followed by another group of 6 patients in a test-retest study. The results of this study will provide crucial information to guide the development of \[18F\]GEH121224 for the detection of HER2 status in advanced breast cancer patients. This study will use established methods for characterizing the radiation dosimetry, biodistribution and basic pharmacokinetics of a radiotracer.

Timeline

Start

2026-02

Primary completion

2026-12

Completion

2026-12

Outcome

Outcome not reported

Stopped (Business): “Business Decision”

Drugs

Indications