RecruitingPhase 2NCT06557733

An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis

Phase 2 Study to Evaluate the Efficacy and Safety of TPST-1495 in Patients With Familial Adenomatous Polyposis (FAP)


Sponsor

National Cancer Institute (NCI)

Enrollment

38 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This open-label phase II trial tests how well TPST-1495 works in reducing the number of polyps in the small bowel and colon in patients with familial adenomatous polyposis (FAP). FAP is an inherited condition in which numerous polyps (growths that protrude from mucous membranes) form on the inside walls of the colon and rectum. It increases the risk for colon cancer. TPST-1495 binds to specific prostaglandin receptors. TPST-1495 is a dual antagonist of the prostaglandin E2 (PGE2) receptor subtypes EP2 and EP4, while sparing the immune-stimulating EP1 and EP3 receptors. TPST-1495 may help reduce the number of polyps in the small bowel and colon in patients with FAP.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Biopsy Procedure, a procedure called Biospecimen Collection, and others for people with colorectal carcinoma and familial adenomatous polyposis. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGEP2/EP4 Antagonist TPST-1495

Given PO

PROCEDUREEsophagogastroduodenoscopy

Undergo EGD

PROCEDUREGastrointestinal Endoscopy

Undergo GI endoscopy

OTHERQuestionnaire Administration

Ancillary studies


Locations(4)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06557733


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