Actively Recruiting
An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
38
Participants Needed
4
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of familial adenomatous polyposis (FAP) confirmed by genetic APC mutation, obligate carrier status, or clinical diagnosis with 100 colorectal adenomas and family history
- Completed prophylactic colectomy or sub-total colectomy with ileo-rectal, ileo-colonic anastomosis, or ileal pouch-anal anastomosis (IPAA) at least 12 months prior without ongoing surgical complications
- Willing to discontinue use of non-steroidal anti-inflammatory drugs (NSAIDs) 5 days before treatment and limit NSAID use during the study
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Karnofsky 60%)
- Leukocyte count 3,000/bcl (2,500/bcl for African American participants)
- Platelet count 100 x 10e9/L
- Hemoglobin 11.5 g/dL
- Total bilirubin 1.5 times institutional upper limit of normal (ULN), unless Gilbert's syndrome
- Alkaline phosphatase 1.5 times institutional ULN
- AST/SGOT and ALT/SGPT 2 times institutional ULN
- Creatinine within institutional ULN
- Urinalysis within normal limits or clinically insignificant
- Chronic suppressive antiviral therapy for herpes simplex virus allowed
- Presence of Spigelman stage 2 or 3 duodenal polyposis
- Not pregnant and not breastfeeding; agreement to use contraception during and 90 days after study
- Ability to understand and sign informed consent
- Helicobacter pylori negative confirmed by gastric biopsy; if positive, must complete eradication and re-assessment prior to enrollment
You will not qualify if you...
- Use of other investigational agents within 12 weeks prior to enrollment
- History of gastric or intestinal ulceration from NSAID therapy
- Uncontrolled illness or recent surgery limiting compliance
- History of invasive malignancy within 3 years except certain treated skin or cervical cancers
- Prior upper gastrointestinal surgery preventing evaluation of 10 cm duodenal segment
- Presence of high grade dysplasia, gastrointestinal bleeding, or need for anticoagulation (except low dose aspirin) after study start
- Use of strong or moderate CYP2D6 and CYP3A4 inhibitors
- HIV infection, even if viral load undetectable
- Chronic hepatitis B or C infection, even if viral load undetectable
- Active untreated or refractory Helicobacter pylori infection
- History of peptic ulcers with bleeding, NYHA class II-IV heart failure, active autoimmune diseases, anticoagulant use with bleeding risk, or abnormal QT interval
- Patients expected to be at significant risk of diverticulitis due to colectomy status
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
3
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
4
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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