Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
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.