Actively Recruiting
A Phase 1b-2, Multicenter Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of REC-4881 in Patients With Familial Adenomatous Polyposis
Led by Recursion Pharmaceuticals Inc. · Updated on 2026-06-05
67
Participants Needed
17
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating REC-4881 in people with Familial Adenomatous Polyposis (FAP), a condition affecting the digestive tract. This Phase 1b/2 trial focuses on participants with classical FAP involving the duodenum or residual colon, rectum, or pouch. The study aims to assess the drug's safety, how it moves through and affects the body, and its impact on the disease. Participants will be assigned to one of several groups receiving different doses or schedules of REC-4881 or a placebo. Treatments include single doses followed by daily doses for two weeks, 12 weeks of daily dosing followed by 12 weeks off, or intermittent dosing over 24 weeks. The study includes two parts, with initial short-term dosing and later longer treatment periods. During the study, participants will undergo regular assessments including blood tests to measure drug levels and monitor safety, endoscopies to evaluate polyp changes, and heart and liver function tests. Researchers will track side effects, dose adjustments, and changes in polyp number and size over up to 37 weeks. Participation involves multiple visits to monitor response and safety throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 18 years or older
- Provided written informed consent to participate
- Diagnosis of classical Familial Adenomatous Polyposis (FAP) with duodenum or residual colon/rectum/pouch involvement
- Genetic diagnosis of FAP with APC gene mutation (Part 2 only)
- Underwent colectomy or subtotal colectomy
- Spigelman Classification Stage II or higher
- Agree to leave polyps 10 mm or smaller unresected during screening and study endoscopies
- No significant cardiovascular abnormalities (ejection fraction >50%, QTcF <450 msec men, <470 msec women)
- No significant hematopoietic abnormalities (specified blood counts and no clinical coagulopathy)
- No significant liver abnormalities (bilirubin ≤1.5 times ULN, AST/ALT/ALP ≤2.0 times ULN)
- No significant kidney abnormalities (serum creatinine ≤1.5 times ULN)
- Women of childbearing potential must have negative pregnancy tests and agree to contraception during and after study
- Absence of gross blood in stool at screening except red blood on toilet paper
- Willing to discontinue NSAIDs 6 weeks prior to study and during treatment (aspirin ≤700 mg/week allowed)
You will not qualify if you...
- Clinically significant medical or psychiatric illness interfering with study or safety
- Prior pelvic irradiation
- Gastrointestinal disease or recent procedure interfering with oral drug absorption
- Treatment with other investigational agents within 4 weeks or 5 half-lives prior to study
- Treatment with other FAP-directed drugs within 8 weeks or Whipple procedure (Part 2 only)
- Current treatment for desmoid tumors
- Use of omega-3 fatty acids or oral corticosteroids before study start
- Use of strong CYP3A inhibitors or inducers before study start
- History of significant eye abnormalities or retinal/corneal diseases
- Cancer in gastrointestinal tract at screening (Part 2 only)
- Large polyps (>1 cm) not removable
- Active pancreatitis or gall bladder disease
- Pregnancy, lactation, or planning pregnancy during or shortly after study
- Major surgery prior to study start
- Active infection requiring systemic therapy
- Known allergy to study drug or ingredients
- History of substance abuse within 1 year or ongoing abuse
- Treatment with MEK inhibitors within 8 weeks prior and during study
- Active infections including uncontrolled HIV, chronic HBV, or HCV
- Severe or uncontrolled medical conditions posing risk
- Use of strong BCRP or MRP2 inhibitors before and during study
- Significant cardiovascular disease within 6 months before first dose including myocardial infarction, arrhythmias, uncontrolled hypertension, pulmonary embolism, QT prolongation, heart failure, myocarditis, or atrial enlargement
- QTcF prolongation above specified limits or history of long QTc syndrome
- Congestive heart failure New York Heart Association class III-IV
- Clinically significant pericarditis or myocarditis
- Atrial enlargement or serious cardiac conditions affecting safety
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 - Up to 24 weeks depending on dosing regimen
Participants receive REC-4881 or placebo capsules orally according to assigned dosing schedules, including single dose followed by once daily dosing or interval dosing over several weeks.
Multiple visits during dosing periods up to 24 weeks
Duration - Up to 12 weeks after treatment
Participants are monitored for safety, treatment-emergent adverse events, and changes in polyp burden after treatment ends.
Visits for assessments up to 12 weeks post-treatment
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
Active, Not Recruiting
9
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Active, Not 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
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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