TPST-1495 for Adenomatous Polyposis

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byNiloy J Samadder

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for patients with familial adenomatous polyposis (FAP), a condition causing many polyps in the colon and increasing colon cancer risk. Details on who can join or reasons for exclusion are not provided.

Inclusion Criteria

I have been diagnosed with FAP due to an APC mutation or clinical criteria.

Ability to understand and sign a written informed consent document

I am 18 years old or older.

+9 more

Exclusion Criteria

Use of any other investigational agents ≤ 12 weeks prior to pre-registration

I have had cancer within the last 3 years, with some exceptions.

I have a confirmed severe precancerous condition or cancer, have had bleeding in my digestive tract, and need blood thinners.

+7 more

Participant Groups

The trial tests TPST-1495, which targets specific receptors to potentially reduce polyp numbers in the small bowel and colon of FAP patients. It involves endoscopies, tissue collection, biopsies, and questionnaires.

1Treatment groups

Experimental Treatment

Group I: Prevention (TPST-1495)Experimental Treatment6 Interventions

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.