Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The overall aim of this feasibility study is to develop new technologies for improved
detection of Barrett's neoplasia using the scanning fiber endoscope (SFE) imaging system.
This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically
to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic
biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide
early evidence of efficacy for the topical application of a peptide dimer that binds to
molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A
dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds
specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human
Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects
with known or suspected Barrett's esophagus.