Study of the Safety of KSP Heptapeptide (KSP-910638G)

Study of the Safety of KSP Heptapeptide (KSP-910638G) in Humans for the Early Detection of GI Malignancies

The purpose of this study is to evaluate the safety of orally administered KSP-910638G, a topically administered li-cor IRDye800CW labeled heptapeptide specific for human epithelial growth factor receptor 2 (HER2).

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: KSP-910638G, 0.4 mg; Drug: KSP-910638G, 1.2 mg

Detailed Description

This is a Phase IA study of the safety of an orally administered KSP-910638G heptapeptide for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 25 evaluable subjects. The investigators expect to be able to enroll about 1-2 subjects per week, so the study should take about 4-6 months to complete.

Interested, healthy subjects ages 25-100 who respond to recruitment advertising on UMHealthResearch.org and appear to be eligible based responses to inclusion/exclusion criteria questions will be scheduled for a study visit at MCRU. At the study visit, the subjects will review and sign the informed consent and eligibility will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a urine sample for urinalysis. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted KSP-910638G. After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water and vital signs will be taken. Subjects will remain in MCRU for observation for 30 minutes. Vital signs will be recorded after 30 minutes. Subjects are required to return to MCRU to have a repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after KSP-910638G ingestion. The study team will conduct a verbal assessment for toxicity at this visit.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Not pregnant (willing to have pregnancy test if applicable)
• No recent illness (infection, URI, virus or flu) within 2 weeks,
• Stable health status (i.e. no medication changes within 2 months, no recent surgery, etc. per PI)
• Willing and able to sign informed consent
• Willing and able to drink the peptide and a tap water chaser
• Willing and able to get baseline and 24-48 hours post ingestion labs

Exclusion Criteria:

• Known allergy to li-cor IRDye800CW, a near infrared fluorosphore or derivatives
• Subjects on active chemotherapy or radiation therapy
• Diabetics on insulin/hypoglycemic (due to fasting requirements)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KSP-910638G 0.4 mg subjects 1-3; The first three subjects will receive lyophilized powder reconstituted with 5 mL of 0.9% NaCl, 0.4 mg of KSP-910638G total. For the first three subjects, 3.34 mL of KSP-910638G will be discarded. The 1.66 mL of KSP-910638G remaining in the syringe will be administered by squirting it into the mouth of the subject.	Drug: KSP-910638G, 0.4 mg; The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (0.4 mg dose)
Experimental: KSP-910638G 1.2 mg subjects 4-25; Following a safety review of the first three subjects receiving 0.4 mg dose, the remaining 22 subjects will receive the full 1.2 mg dose of KSP-910638G reconstituted in 5 mL 0.9% NaCl. These 22 subjects will receive all 5 mL of the peptide solution in a syringe for administration. The agent will not be reconstituted until the subject is ready to squirt the peptide into his or her mouth via syringe. They will be asked to wait 5 minutes and then drink at least 4-8 oz of tap water.	Drug: KSP-910638G, 1.2 mg; The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (1.2 mg dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with abnormal lab values	review of laboratory values for abnormalities after intervention with KSP-910638G	48 hours

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Study Chair: Ashley E Cawthon, Michigan Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): September 20, 2017
• Study Completion (Actual): September 20, 2017

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HUM00126486

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No