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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Familial Adenomatous Polyposis

In brief

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

Key facts

Study ID: NCT05552755
Run by: Recursion Pharmaceuticals Inc.
People needed: 67
Starts: 2023-07-10
Expected to finish: 2027-09-01
Last updated by the study team: 2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female and ≥ 18 years of age
Have provided written informed consent to participate in the study
Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
Genetic diagnosis of FAP with APC gene mutation (Part 2 only).
Has undergone colectomy or subtotal colectomy
Spigelman Classification Stage II or higher.
Investigator/Participant agrees to leave polyps ≤10 mm unresected during endoscopies performed at Screening and while on study
Have no significant cardiovascular abnormalities at Screening:
Left ventricular ejection fraction >50% as determined on screening echocardiogram (ECHO)/ multi-gated acquisition (MUGA)
A QT interval corrected for heart rate using the Fridericia formula (QTcF) < 450 msec in men and <470 milliseconds (msec) in women.
Have no significant hematopoietic abnormalities at Screening:
White blood cell count (WBC) ≥ 3,000/cubic millimeters (mm\^3) (non-black populations); 2,700/mm\^3 (black populations)
Platelet count ≥ 120,000/mm\^3
Hemoglobin ≥ 10.0 grams (g)/deciiter (dL)
No history of clinical coagulopathy.
Have no significant hepatic abnormalities at Screening:
Total bilirubin ≤ 1.5 * upper limit of normal (ULN) (individuals with Gilbert syndrome may be enrolled)
Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 2.0 * ULN.
Have no significant renal abnormalities at Screening: serum creatinine ≤ 1.5 times * ULN.
Female participants who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours before the first dose of study drug. If the urine test is positive or cannot be confirmed negative, a serum pregnancy test will be required and must be negative for the participant to be eligible.
All participants must be willing to follow the contraceptive guidance in the protocol and must not be lactating or planning to attempt to become pregnant during the study or for a further period of 4 months after the last dose of study drug or impregnate someone during this study or for a further period of 14 weeks after the last dose of study drug.
Absence of gross blood in stool at Screening; red blood on toilet paper only is acceptable.
Participant must be willing to discontinue use of non-steroidal anti-inflammatory agents (NSAIDs) 6 weeks prior to Study Day 1 and remain off NSAIDs throughout the treatment period of the study (use of aspirin ≤ 700 milligrams [mg] week is allowed.)

You may not qualify if…

Has any clinically significant laboratory abnormality, medical or psychiatric illness which, in the opinion of the Investigator, could interfere with the conduct or interpretation of the study or put the participant at risk.
Has had prior pelvic irradiation.
Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881, including difficulty swallowing capsules.
Has received treatment with other investigational agents within the 4 weeks prior to Study Day 1 or a period during which the investigational agent has not been cleared from the body (that is, at least a period of 5 half-lives, if known), whichever is longer.
Treatment with other FAP-directed drug therapy (such as off-label use of Balsalazide) within 8 weeks of screening endoscopy (Part 2 only) or had a Whipple procedure.
Is currently under treatment for desmoid tumors.
Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1
Use of strong cytochrome P3A (CYP3A) inhibitors or inducers prior to Study Day 1
History of an ongoing or newly diagnosed eye abnormality, including:
Retinal pathologies such as diabetic retinopathy, veno-occlusion, or macular edema
Corneal pathologies such as herpes keratitis, corneal dystrophy, corneal erosions, corneal degeneration, active or recurrent keratitis, or uveitis (intermittent, posterior, and/or panuveitis)
Other clinically significant ophthalmologic abnormalities (for example, retinal detachment) or has findings at Screening. [Participants with corrected myopia may be enrolled.]
Has cancer at screening endoscopy in gastrointestinal (GI) tract (including stomach, duodenum, and colon/rectum/pouch) (Part 2 only).
Has a large polyp (>1 centimeter [cm]) not amenable to complete removal
Has active pancreatitis secondary to pancreatic duct obstruction
Has active gall bladder disease
Is pregnant, lactating or is planning to attempt to become pregnant during this study or within 4 months after the last dose of study drug (women) or is planning to attempt to impregnate someone or donate sperm during the study or within 14 weeks after the last dose of study drug (men).
Has had major surgery prior to Study Day 1
Has an active infection requiring systemic therapy.
Has known hypersensitivity to the study drug or its excipients.
Has a history of alcohol or substance abuse within 1 year prior to screening for study participation, or is currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which, in the opinion of the Investigator, indicates abuse.
Received treatment with another mitogen-activated protein kinase (MEK) inhibitor 8 weeks prior to Screening and throughout the treatment period of the study.
Any of the following known active infections:
Human immunodeficiency virus (HIV) not optimally controlled or treated. Participants with HIV who are on sustained stable antiretrovirals (for >4 weeks) and have cluster of differentiation (CD)4+ counts ≥ 350 cells/microliter (μL) may be enrolled. No HIV testing is required unless clinically indicated or mandated by local health authority.
Chronic hepatitis B virus (HBV) infection with surface antigen positive: participants with a prior history of treated HBV infection who are hepatitis B surface antigen-negative may be enrolled. No testing is required for hepatitis B unless clinically indicated or mandated by local health authority.

Where it is running

University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
Vanderbilt Digestive Center — Nashville, Tennessee, United States (enrolling)
Genetic Cancer Prevention Clinic - UT Southwestern — Dallas, Texas, United States (enrolling)
MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
Huntsman Cancer Institute and University of Utah — Salt Lake City, Utah, United States (enrolling)
Benaroya Research Institute at Virginia Mason — Seattle, Washington, United States (enrolling)
Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis) — Grand Rapids, Michigan, United States
Mayo Clinic - Scottsdale — Scottsdale, Arizona, United States
Gastro One-8110 Walnut Rs — Cordova, Tennessee, United States
Mayo Clinic - Rochester — Rochester, Minnesota, 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

Full record on ClinicalTrials.gov

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