Actively Recruiting
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
Led by Recursion Pharmaceuticals Inc. · Updated on 2026-04-16
67
Participants Needed
17
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, two-part trial in participants with FAP.
CONDITIONS
Official Title
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Provided written informed consent to participate
- Diagnosed with classical FAP with disease involvement of the duodenum or residual colon/rectum/pouch
- Genetic diagnosis of FAP with APC gene mutation (Part 2 only)
- Have undergone colectomy or subtotal colectomy
- Spigelman Classification Stage II or higher
- Agree to leave polyps 10 mm or smaller unresected during endoscopies at screening and on study
- No significant cardiovascular abnormalities at screening, including left ventricular ejection fraction >50% and QTcF <450 msec in men and <470 msec in women
- No significant hematopoietic abnormalities at screening, including minimum white blood cell and platelet counts, hemoglobin ≥10.0 g/dL, and no history of clinical coagulopathy
- No significant hepatic abnormalities at screening, including bilirubin ≤1.5 times upper limit of normal and AST, ALT, ALP ≤2 times upper limit
- No significant renal abnormalities at screening with serum creatinine ≤1.5 times upper limit
- Female participants of childbearing potential must have negative pregnancy tests at screening and before first dose
- Willing to follow contraceptive guidance and not lactating or planning pregnancy during study and for specified periods after
- No gross blood in stool at screening (red blood on toilet paper only acceptable)
- Willing to discontinue NSAIDs 6 weeks prior to study Day 1 and remain off during treatment, with aspirin ≤700 mg/week allowed
You will not qualify if you...
- Any clinically significant lab abnormality, medical or psychiatric illness that could interfere with study or pose risk
- Prior pelvic irradiation
- Gastrointestinal disease or recent procedure affecting oral absorption of REC-4881
- Treatment with other investigational agents within 4 weeks or not cleared from body
- Treatment with other FAP-directed drugs within 8 weeks of screening or Whipple procedure (Part 2 only)
- Current treatment for desmoid tumors
- Use of omega-3 fatty acids or oral corticosteroids before study Day 1
- Use of strong CYP3A inhibitors or inducers before study Day 1
- History of significant eye abnormalities or findings at screening
- Cancer in GI tract at screening endoscopy (Part 2 only)
- Large polyp >1 cm not removable
- Active pancreatitis or gall bladder disease
- Pregnant, lactating, or planning pregnancy or impregnating during study or specified post-study periods
- Major surgery before study Day 1
- Active infection requiring systemic therapy
- Known hypersensitivity to study drug or excipients
- History of alcohol or substance abuse within 1 year or current abuse
- Treatment with MEK inhibitors within 8 weeks before screening and during treatment
- Active uncontrolled infections including certain HIV, HBV, HCV statuses
- Severe or uncontrolled medical conditions posing significant risk
- Use of strong BCRP or MRP2 inhibitors within 14 days before study Day 1 and during treatment
- Significant cardiovascular disease within 6 months before first dose including myocardial infarction, arrhythmias, uncontrolled hypertension, pulmonary embolism, QTcF prolongation, congestive heart failure, myocarditis, or atrial enlargement
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
Active, Not Recruiting
2
Del Sol Research Management
Tucson, Arizona, United States, 85715
Withdrawn
3
Medical Associates Research Group
San Diego, California, United States, 92123
Withdrawn
4
GI Pros
Naples, Florida, United States, 34102
Withdrawn
5
Digestive and Liver Center of Florida
Orlando, Florida, United States, 32825
Terminated
6
Gastroenterology Health Partners, PLLC
New Albany, Indiana, United States, 47150
Withdrawn
7
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
Terminated
8
Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis)
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
9
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
11
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Gastro One-8110 Walnut Rs
Cordova, Tennessee, United States, 38108
Terminated
13
Vanderbilt Digestive Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
14
Genetic Cancer Prevention Clinic - UT Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
Huntsman Cancer Institute and University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
17
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
R
Recursion Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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