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

Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Contrast in Cell Fluorescence

Condition

Cholangiocarcinoma

Intervention

KSP/QRH dimer

Study Arms / Comparison Groups

 Dimer Application with SFE imaging

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

12

Start Date

September 22, 2020

Completion Date

December 17, 2021

Primary Completion Date

December 17, 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Danielle Kim Turgeon, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT04304781

Organization ID

HUM00173620

Responsible Party

Sponsor-Investigator

Study Sponsor

Danielle Kim Turgeon

Study Sponsor

Danielle Kim Turgeon, MD, Principal Investigator, University of Michigan

Verification Date

November 2022