NCT04304781

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

Phase 1 In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Biliary Intra-epithelial Neoplasia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Danielle Kim Turgeon · 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 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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	KSP/QRH dimer	Peptide 919288G, Lot No. 17081402, Molecular Weight 3577.0, ≥95% purity. Stored at \<20°C. Dark green, lyophilized powder in single-use amber vials.

Timeline

• Start date: 2020-09-22
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2020-03-11
• Last updated: 2022-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study