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

NCT ID: NCT04304781

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2021-12-17

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.

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

KSP/QRH dimer

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danielle Kim Turgeon

OTHER

Sponsor Role: lead

Responsible Party

Danielle Kim Turgeon

Professor of Internal Medicine and Clinical Track Faculty Ombuds, Medical School, Int Med-Gastroenterology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Danielle Kim Turgeon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Michigan Medicine

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00173620

Identifier Type: -

Identifier Source: org_study_id