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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06557733
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • EP2/EP4 Antagonist TPST-1495 — DRUG
    Given PO
  • Esophagogastroduodenoscopy — PROCEDURE
    Undergo EGD
  • Gastrointestinal Endoscopy — PROCEDURE
    Undergo GI endoscopy
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Prevention (TPST-1495)
    Patients receive TPST-1495 PO QD for 6 months in the absence of unacceptable toxicity. Patients also undergo EGD and GI endoscopy with biopsy at baseline and end of treatment and undergo blood sample collection throughout the study.

Primary Outcome Measure

Percent change in duodenal polyp burden [ Time Frame: Baseline to 6 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054
Niloy J. Samadder
[email protected]
480-342-6263
Niloy J. Samadder (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Lisa A. Boardman
[email protected]
507-284-2175
Lisa A. Boardman (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Jessica R. Stout
[email protected]
801-585-6439
Jessica R. Stout (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792
Lisa M. Barroilhet
[email protected]
608-265-2319
Lisa M. Barroilhet (PRINCIPAL_INVESTIGATOR)

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