Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer

Status Terminated

Clinical Trial Summary

The overall aim of this feasibility study is to develop new technologies for improved detection of cholangiocarcinoma using the SFE-based molecular-imaging mini-cholangioscope (MC) system. This study will combine the use of a fluorescent-labeled peptide dimer that binds specifically to know biomarkers of cholangiocarcinoma for use as a novel imaging agent to guide endoscopic biopsies. 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 that are specific for biliary intra-epithelial neoplasia. A dimer is needed because cancer in the biliary tract 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 having a medical condition requiring an ERCP to diagnose a potential biliary disorder. The Phase 1A first-in-human studies of safety with topical administration by ingestion of KSP/QRH dimer (HUM00141420) has been completed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cholangiocarcinoma

Clinical Trial Details

NCT number	NCT04304781
Study type	Interventional
Source	University of Michigan
Contact
Status	Terminated
Phase	Phase 1
Start date	September 22, 2020
Completion date	December 17, 2021

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