NCT05552755 · Recursion Pharmaceuticals Inc.
Evaluate REC-4881 in Patients With FAP
(TUPELO)
What this study is about
This is a conducted at multiple hospitals, two-part trial in participants with Familial Adenomatous Polyposis (FAP).
View original scientific description
This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis (FAP).
Interventions
DRUG
REC-4881
REC-4881 capsules
DRUG
Placebo
Placebo capsules
Primary outcome measures
Part 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881
Time frame: Day 1 through Day 43
Part 1: Time to Reach Cmax (Tmax) of REC-4881
Time frame: Day 1 through Day 43
Part 1: Area Under the Plasma Concentration-time Curve (AUC) of REC-4881
Time frame: Day 1 through Day 43
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
Part 2: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: First 28 days of treatment
Part 2: Number of Participants Who Discontinued Treatment
Time frame: Day 1 through up to Week 37
Part 2: Number of Participants With Dose Modification Due to Toxicity
Time frame: Day 1 through up to Week 37
Part 2: Percent Change From Baseline in Polyp Burden
Time frame: Baseline, up to Week 37
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female and ≥ 55 years of age 2. Have provided written informed consent 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. Left ventricular ejection fraction \>50% as determined on screening echocardiogram 2. A QT interval corrected for heart rate using the Fridericia formula (QTcF) \< 450 msec in men and \<470 msec in women. 9. Have no significant hematopoietic abnormalities at Screening: 1. White blood cell count (WBC) ≥ 3,000/mm3 (non-black populations); 2,700/mm3 (
Where
- Scottsdale, Arizona
- Tucson, Arizona
- San Diego, California
- Naples, Florida
- Orlando, Florida
- New Albany, Indiana
- Marrero, Louisiana
- Grand Rapids, Michigan
- Rochester, Minnesota
- St Louis, Missouri
- Philadelphia, Pennsylvania
- Cordova, Tennessee
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations