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

November 17, 2022 updated by: Danielle Kim Turgeon

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
Peptide 919288G, Lot No. 17081402, Molecular Weight 3577.0, ≥95% purity. Stored at <20°C. Dark green, lyophilized powder in single-use amber vials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast in Cell Fluorescence
Time Frame: During and immediately after procedure, generally no more than 2 hours
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.
During and immediately after procedure, generally no more than 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 22, 2020

Primary Completion (ACTUAL)

December 17, 2021

Study Completion (ACTUAL)

December 17, 2021

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (ACTUAL)

March 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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