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

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



Sponsors


Source

University of Michigan

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


Brief Summary

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).

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.

Overall Status

Active, not recruiting

Start Date

2017-06-21

Completion Date

2017-12-01

Primary Completion Date

2017-12-01

Phase

Phase 1

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Number of subjects with abnormal lab values
48 hours

Enrollment

26

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

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)

Arm Group Label

KSP-910638G 0.4 mg subjects 1-3


Intervention Type

Drug

Intervention Name


Description

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)

Arm Group Label

KSP-910638G 1.2 mg subjects 4-25



Eligibility

Criteria

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)

Gender

All

Minimum Age

25 Years

Maximum Age

100 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Ashley E Cawthon
Study Chair
Michigan Medicine

Overall Contact

Last Name

Danielle K Turgeon, MD

Phone

734-764-6860

Email



Location

Facility

University of Michigan
Ann Arbor Michigan 48109 United States

Location Countries

Country

United States


Verification Date

2017-11-01

Lastchanged Date

2017-11-01

Firstreceived Date

2017-05-18

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Michigan

Investigator Full Name

Danielle Kim Turgeon

Investigator Title

Professor of Internal Medicine, Medical School


Has Expanded Access

No

Number Of Arms

2

Arm Group

Arm Group Label

KSP-910638G 0.4 mg subjects 1-3

Arm Group Type

Experimental

Description

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.


Arm Group Label

KSP-910638G 1.2 mg subjects 4-25

Arm Group Type

Experimental

Description

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.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Elaine M Brady, MBA

Phone

734-647-4794

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Other

Masking

None (Open Label)


Study First Submitted

May 18, 2017

Study First Submitted Qc

May 18, 2017

Study First Posted

May 19, 2017

Last Update Submitted

November 1, 2017

Last Update Submitted Qc

November 1, 2017

Last Update Posted

November 6, 2017


ClinicalTrials.gov processed this data on November 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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