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

Sponsor

Danielle Kim Turgeon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04304781

Collaborator

(none)

Enrollment

Location

Arm

26.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma	Drug: KSP/QRH dimer	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Sep 22, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dimer Application with SFE imaging Subjects having a standard-of-care ERCP will have the dimer sprayed on an area of interest in the bile duct and images taken with the SFE.	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.

Arm

Intervention/Treatment

Experimental: Dimer Application with SFE imaging

Subjects having a standard-of-care ERCP will have the dimer sprayed on an area of interest in the bile duct and images taken with the SFE.

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.

Outcome Measures

Primary Outcome Measures

Contrast in Cell Fluorescence [2 years]
The fluorescence intensity will be measured by the target/background (T/B) ratio from suspicious regions of bile duct where the fluorescent-labeled peptide is administered. The intensity of the fluorescence of the abnormal tissue compared to the background tissue intensity will be analyzed using statistical analysis for significance comparing the tissue groups' mean T/B ratios.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject meets all of the following criteria:

Scheduled for an outpatient ERCP to diagnose a potential biliary disorder (such as an indeterminate biliary stricture)
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 any components of the study drug (list these)
Subjects on active chemotherapy or radiation treatment
Pregnant or trying to conceive
Anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michigan Medicine	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

Danielle Kim Turgeon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Danielle Kim Turgeon, Professor of Internal Medicine and Clinical Track Faculty Ombuds, Medical School, Int Med-Gastroenterology, University of Michigan

ClinicalTrials.gov Identifier:

NCT04304781

Other Study ID Numbers:

HUM00173620

First Posted:

Mar 11, 2020

Last Update Posted:

Dec 15, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cholangiocarcinoma

Study Results

No Results Posted as of Dec 15, 2021