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

  • STATUS
    Recruiting
  • End date
    Dec 22, 2022
  • participants needed
    25
  • sponsor
    Danielle Kim Turgeon
Updated on 22 December 2021
cancer
anticoagulants
HER2
EGFR

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.

Details
Condition Cholangiocarcinoma
Treatment KSP/QRH dimer
Clinical Study IdentifierNCT04304781
SponsorDanielle Kim Turgeon
Last Modified on22 December 2021

Eligibility

Yes No Not Sure

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
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