Actively Recruiting
Phase 2 Study to Evaluate the Efficacy and Safety of TPST-1495 in Patients With Familial Adenomatous Polyposis (FAP)
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
38
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the investigational drug TPST-1495 in patients with familial adenomatous polyposis (FAP), an inherited condition causing numerous polyps in the colon and rectum that increase the risk of colon cancer. This open-label phase II trial aims to assess how well TPST-1495 reduces the number of polyps in the small bowel and colon while also monitoring safety by tracking adverse events. Participants receive TPST-1495 orally once daily for six months if they do not experience unacceptable side effects. During the study, patients undergo esophagogastroduodenoscopy (EGD) and gastrointestinal endoscopy with biopsies at the start and end of treatment. Blood samples are collected throughout the study to support additional research objectives. Throughout the trial, researchers will measure changes in duodenal and rectal polyp burden, evaluate tissue samples for markers like COX-2, beta-catenin, and Ki-67, and analyze serum proteomic profiles. After completing treatment, participants have a follow-up visit one month later. The total study participation spans approximately seven months, including treatment and safety monitoring.
CONDITIONS
Brief 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) by genetic testing, obligate carrier status, or clinical diagnosis with at least 100 colorectal adenomas and family history
- Previously underwent prophylactic colectomy or sub-total colectomy with ileo-rectal or ileo-colonic anastomosis or IPAA at least 12 months before evaluation without ongoing surgical complications
- Willing to discontinue NSAIDs 5 days before starting study treatment and limit NSAID use during the trial
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Leukocytes (white blood count) ≥ 3,000/uL (≥ 2,500/uL for African American participants)
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 11.5 g/dL
- Total bilirubin ≤ 1.5 times institutional upper limit 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
- Urinary testing results within normal limits or clinically insignificant
- Individuals on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
- Presence of Spigelman stage 2 or 3 duodenal polyposis by endoscopy
- Not pregnant or breastfeeding; women of child-bearing potential and men must agree to use contraception during and for 90 days after study participation
- Ability to understand and sign informed consent
- Helicobacter pylori negative confirmed by gastric biopsy or successfully treated with confirmed eradication
You will not qualify if you...
- Use of other investigational agents within 12 weeks prior to enrollment
- History of gastric or intestinal ulceration due to NSAID therapy
- Uncontrolled illness or recent surgery that limits compliance
- History of invasive malignancy within 3 years prior except certain treated skin or cervical cancers
- History of upper GI surgery preventing evaluation of duodenum segment
- Presence of high grade dysplasia, cancer, gastrointestinal bleeding, or need for anticoagulation except low dose aspirin
- Use of strong or moderate CYP2D6 and CYP3A4 inhibitors
- Evidence of HIV infection regardless of viral load
- Evidence of chronic hepatitis B or C infection regardless of viral load
- Active 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 QTc prolongation
- Patients with status post colectomy or subtotal colectomy expected not at significant risk for diverticulitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive the investigational drug TPST-1495 orally once daily for 6 months while undergoing endoscopic procedures and blood sample collection.
1 baseline endoscopy visit, regular blood sample collections during treatment, and 1 end of treatment endoscopy visit
Duration - 1 month
Participants are followed up 1 month after completing study treatment to monitor safety and health status.
1 follow-up visit (in-person)
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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