ClinicalTrials.gg
RecruitingNCT05552755TUPELOUpdated Jun 5, 2026

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

A Phase 1/2 interventional study of REC-4881 and Placebo in Familial Adenomatous Polyposis, sponsored by Recursion Pharmaceuticals Inc.. Recruiting at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Recursion Pharmaceuticals Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 4 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
67
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

This is a Phase 1b/2 trial to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of REC-4881 in participants with FAP. This two-part study will treat participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.

02

Conditions studied

  • Familial Adenomatous Polyposis

Keywords

  • FAP
  • familial adenomatous polyposis
  • APC mutation
  • adenomatous polyposis coli
  • desmoid disease
03

In context

Adenomatous Polyposis Coli

92 studies on the registry are indexed under Adenomatous Polyposis Coli; 29 are open to participants now.

This study's planned enrollment of 67 is above the median of 40 across 61 interventional studies indexed under Adenomatous Polyposis Coli.

Browse Adenomatous Polyposis Coli studies →

Lead sponsor

Recursion Pharmaceuticals Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female and ≥ 18 years of age
  2. Have provided written to participate in the study
  3. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
  4. Genetic diagnosis of FAP with APC gene mutation (Part 2 only).
  5. Has undergone colectomy or subtotal colectomy
  6. Spigelman Classification Stage II or higher.
  7. Investigator/Participant agrees to leave polyps ≤10 mm unresected during endoscopies performed at Screening and while on study
  8. Have no significant cardiovascular abnormalities at Screening:

    1. >50% as determined on screening echocardiogram (ECHO)/ multi-gated acquisition (MUGA)
    2. A corrected for heart rate using the Fridericia formula (QTcF) \< 450 msec in men and \<470 milliseconds (msec) in women.
  9. Have no significant hematopoietic abnormalities at Screening:

    1. White blood cell count (WBC) ≥ 3,000/cubic millimeters (mm\^3) (non-black populations); 2,700/mm\^3 (black populations)
    2. count ≥ 120,000/mm\^3
    3. ≥ 10.0 grams (g)/deciiter (dL)
    4. No history of clinical coagulopathy.
  10. Have no significant hepatic abnormalities at Screening:

    1. Total ≤ 1.5 * (ULN) (individuals with Gilbert syndrome may be enrolled)
    2. (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 2.0 * ULN.
  11. Have no significant renal abnormalities at Screening: serum creatinine ≤ 1.5 times * ULN.
  12. Female participants who are women of (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.
  13. All participants must be willing to follow the 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.
  14. Absence of gross blood in stool at Screening; red blood on toilet paper only is acceptable.
  15. 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.)

Exclusion criteria

Exclusion Criteria:

  1. Has any 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.
  2. Has had prior pelvic irradiation.
  3. Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881, including difficulty swallowing capsules.
  4. Has received treatment with other 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.
  5. 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.
  6. Is currently under treatment for desmoid tumors.
  7. Use of omega-3 fatty acids or oral prior to Study Day 1
  8. Use of strong cytochrome P3A () inhibitors or inducers prior to Study Day 1
  9. History of an ongoing or newly diagnosed eye abnormality, including:

    1. Retinal pathologies such as diabetic retinopathy, veno-occlusion, or macular edema
    2. Corneal pathologies such as herpes keratitis, corneal dystrophy, corneal erosions, corneal degeneration, active or recurrent keratitis, or uveitis (intermittent, posterior, and/or panuveitis)
    3. Other clinically significant ophthalmologic abnormalities (for example, retinal detachment) or has findings at Screening. [Participants with corrected myopia may be enrolled.]
  10. Has cancer at screening endoscopy in gastrointestinal (GI) tract (including stomach, duodenum, and colon/rectum/pouch) (Part 2 only).
  11. Has a large polyp (>1 centimeter [cm]) not amenable to complete removal
  12. Has active pancreatitis secondary to pancreatic duct obstruction
  13. Has active gall bladder disease
  14. 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).
  15. Has had major surgery prior to Study Day 1
  16. Has an active infection requiring systemic therapy.
  17. Has known to the study drug or its .
  18. 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.
  19. Received treatment with another mitogen-activated protein kinase (MEK) inhibitor 8 weeks prior to Screening and throughout the treatment period of the study.
  20. Any of the following known active infections:

    1. (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.
    2. Chronic 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.
    3. Chronic virus (HCV) infection: untreated or on active treatment. Participants with a prior history of treated HCV infection who are HCV RNA-undetectable may be enrolled. No testing is required for hepatitis C unless clinically indicated or mandated by local health authority.
  21. Has a severe or uncontrolled medical condition (for example, dermatologic disease, etc.) that, in the opinion of the Investigator, would pose a significant clinical risk for the participant.
  22. Use of strong Breast Cancer Resistance Protein (BCRP) or Multidrug Resistance-Associated Protein 2 (MRP2) inhibitors within 14 days of Study Day 1 and throughout the treatment period of the study.
  23. Clinically significant cardiovascular disease ≤ 6 months before first dose

    1. Myocardial infarction or unstable angina
    2. Clinically significant cardiac arrhythmias
    3. Uncontrolled hypertension: systolic blood pressure (SBP) > 180 millimeters of mercury (mmHg), diastolic blood pressure (DBP) > 100 mmHg
    4. Pulmonary embolism, symptomatic cerebrovascular events or any other serious cardiac condition (for example, pericardial effusion or restrictive cardiomyopathy)
    5. prolongation >450 msec in males and >470 msec in females at screening or history of long QTc syndrome
    6. Congestive heart failure ( class III-IV)
    7. Myocarditis / clinically significant pericarditis.
    8. Atrial enlargement.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
67 participants (estimated)

Study arms

  • Placebo comparator
    Placebo (Part 1)

    Participants will receive a single dose of placebo administered orally and then, following 14-28 days, participants will begin once daily (QD) dosing for another 14 days.

    Drug: Placebo

  • Experimental
    REC-4881 4 mg (Part 1)

    Participants will receive REC-4881 4 milligrams (mg) administered orally and then, following 14-28 days, participants will begin QD dosing for another 14 days.

    Drug: REC-4881

  • Experimental
    REC-4881 4 mg (Part 2): QD Treatment Regimen

    Participants will receive REC-4881 4 mg administered orally QD for 12 weeks followed by a 12 week off-treatment period.

    Drug: REC-4881

  • Experimental
    REC-4881 8 mg (Part 2): QD Treatment Regimen

    Participants will receive REC-4881 8 mg administered orally QD for 12 weeks followed by a 12 week off-treatment period.

    Drug: REC-4881

  • Experimental
    REC-4881 4 mg (Part 2): Interval Dosing Treatment Regimen

    Participants will receive REC-4881 4 mg administered orally in a 7 day on and off schedule for 24 weeks.

    Drug: REC-4881

Interventions

  • REC-4881 capsules

  • DrugPlacebo

    Placebo capsules

06

What researchers measure

Primary outcomes

  1. Part 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881

    Time frame: Day 1 through Day 43

  2. Part 1: Time to Reach Cmax (Tmax) of REC-4881

    Time frame: Day 1 through Day 43

  3. Part 1: Area Under the Plasma Concentration-time Curve (AUC) of REC-4881

    Time frame: Day 1 through Day 43

  4. Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 through up to Week 37

  5. Part 2: Number of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: First 28 days of treatment

  6. Part 2: Number of Participants Who Discontinued Treatment

    Time frame: Day 1 through up to Week 37

  7. Part 2: Number of Participants With Dose Modification Due to Toxicity

    Time frame: Day 1 through up to Week 37

  8. Part 2: Percent Change From Baseline in Polyp Burden

    Time frame: Baseline, up to Week 37

Secondary outcomes

  1. Part 1: Number of Participants With TEAEs and SAEs

    Time frame: Day 1 through Day 29

  2. Part 1: Number of Participants Who Discontinued Treatment

    Time frame: Day 1 through Day 29

  3. Part 1: Number of Participants With Dose Modification Due to Toxicity

    Time frame: Day 1 through Day 29

  4. Part 2: Cmax of REC-4881

    Time frame: Week 1 and Week 3

  5. Part 2: Tmax of REC-4881

    Time frame: Week 1 and Week 3

  6. Part 2: Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of REC-4881

    Time frame: Week 1 and Week 3

  7. Part 2: Change From Baseline in Polyp Number

    Time frame: Baseline, up to Week 37

  8. Part 2: Change From Baseline in Polyp Number >5 Millimeters (mm)

    Time frame: Baseline, up to Week 37

  9. Part 2: Change From Baseline in Highest Histological Grade of Polyp

    Time frame: Baseline, up to Week 37

  10. Part 2: Change From Baseline in Spigelman Stage Classification for Duodenal Polyps

    Time frame: Baseline, up to Week 37

  11. Part 2: Change From Baseline in inSiGHT Stage for Rectal/Pouch Polyposis

    Time frame: Baseline, up to Week 37

07

Study locations

7 of 17 sites recruiting
  • Mayo Clinic - Scottsdale
    Scottsdale, Arizona 85259, United States
    Active, not recruiting

    Not enrolling at this site.

  • Del Sol Research Management
    Tucson, Arizona 85715, United States
    Withdrawn

    Not enrolling at this site.

  • Medical Associates Research Group
    San Diego, California 92123, United States
    Withdrawn

    Not enrolling at this site.

  • GI Pros
    Naples, Florida 34102, United States
    Withdrawn

    Not enrolling at this site.

  • Digestive and Liver Center of Florida
    Orlando, Florida 32825, United States
    Terminated

    Not enrolling at this site.

  • Gastroenterology Health Partners, PLLC
    New Albany, Indiana 47150, United States
    Withdrawn

    Not enrolling at this site.

  • Tandem Clinical Research
    Marrero, Louisiana 70072, United States
    Terminated

    Not enrolling at this site.

  • Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis)
    Grand Rapids, Michigan 49503, United States
    Active, not recruiting

    Not enrolling at this site.

  • Mayo Clinic - Rochester
    Rochester, Minnesota 55905, United States
    Active, not recruiting

    Not enrolling at this site.

  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    Recruiting
    • Asima Badic · Contactasimabadic@wustl.edu · 314-362-2646
    • Paul Wise, MD · Principal investigator
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Gastro One-8110 Walnut Rs
    Cordova, Tennessee 38108, United States
    Terminated

    Not enrolling at this site.

  • Vanderbilt Digestive Center
    Nashville, Tennessee 37232, United States
    Recruiting
    • Casey Koza · Contactcasey.koza@vumc.org · (615) 875-6642
    • Reid Ness, MD · Principal investigator
  • Genetic Cancer Prevention Clinic - UT Southwestern
    Dallas, Texas 75390, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
    • Diane Weber · Contactdweber@mdanderson.org · (713) 563-5752
    • Eduardo Vilar-Sanchez, MD · Principal investigator
  • Huntsman Cancer Institute and University of Utah
    Salt Lake City, Utah 84112, United States
    Recruiting
  • Benaroya Research Institute at Virginia Mason
    Seattle, Washington 98101, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2023 (actual). Primary completion is estimated for Jun 2027, 47 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2022
First posted
Sep 23, 2022
StartActual
Jul 10, 2023
Primary completionEst.
Jun 2027
CompletionEst.
Sep 2027
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05552755
Lead sponsor
Recursion Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Sep 23, 2022
Start date
Jul 10, 2023
Primary completion
Jun 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jun 5, 2026

Study contacts

Recursion Pharmaceuticals
Contact
clinicaltrials@recursion.com
385-374-1724

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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