RecruitingPhase 1Phase 2NCT05552755

Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)

A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokintetics, and Pharmacodynamics of REC-4881 in Patients With Familial Adenomatous Polyposis (FAP)

Sponsor

Recursion Pharmaceuticals Inc.

Enrollment

67 participants

Start Date

Jul 10, 2023

Study Type

INTERVENTIONAL

Conditions

Familial Adenomatous Polyposis

Summary

This is a multicenter, two-part trial in participants with FAP.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called REC-4881 in people with familial adenomatous polyposis (FAP) — a hereditary condition that causes hundreds of polyps to grow in the colon and other parts of the digestive tract, which can lead to cancer if not treated. **You may be eligible if...** - You are 18 or older - You have been diagnosed with FAP and have polyps in your duodenum (upper small intestine) or remaining colon, rectum, or pouch - You have previously had a colectomy (colon removal surgery) - Your polyps in the small intestine are at a Spigelman Stage II or higher (moderate involvement) - Your heart function is normal **You may NOT be eligible if...** - You have severe polyp involvement that requires immediate removal - You have significant heart problems (low heart pump function or abnormal heart rhythm) - You have active serious infections or immune deficiency - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREC-4881

REC-4881 capsules

DRUGPlacebo

Placebo capsules

Locations(17)

Mayo Clinic - Scottsdale

Scottsdale, Arizona, United States

Del Sol Research Management

Tucson, Arizona, United States

Medical Associates Research Group

San Diego, California, United States

GI Pros

Naples, Florida, United States

Digestive and Liver Center of Florida

Orlando, Florida, United States

Gastroenterology Health Partners, PLLC

New Albany, Indiana, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis)

Grand Rapids, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Gastro One-8110 Walnut Rs

Cordova, Tennessee, United States

Vanderbilt Digestive Center

Nashville, Tennessee, United States

Genetic Cancer Prevention Clinic - UT Southwestern

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute and University of Utah

Salt Lake City, Utah, United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05552755

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