NCT03852576

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
DRUG	KSP/QRH dimer	KSP-QRH-E3-IRDye800 (Peptide 919288G)

Timeline

• Start date: 2019-05-09
• Primary completion: 2020-11-18
• Completion: 2020-11-18
• First posted: 2019-02-25
• Last updated: 2022-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study