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

NCT06557733 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

EP2/EP4 Antagonist TPST-1495

Given PO

PROCEDURE

Esophagogastroduodenoscopy

Undergo EGD

PROCEDURE

Gastrointestinal Endoscopy

Undergo GI endoscopy

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Niloy J Samadder · University of Wisconsin Carbone Cancer Center - University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06557733 on ClinicalTrials.gov