Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus

Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus

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.

Inclusion Criteria:

• Has known or suspected Barrett's esophagus
• Scheduled for a clinically-indicated, upper endoscopy
• Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
• Age 18 to 100 years
• Willing and able to sign informed consent

Exclusion Criteria:

• Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives
• Subjects on active chemotherapy or radiation treatment
• Pregnant or trying to conceive