Evaluate REC-4881 in Patients With FAP

Eligibility Criteria

• 1. 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. No significant cardiovascular abnormalities
• 7. Left ventricular ejection fraction of \>50% as determined by echocardiogram
• 8. No significant hematopoietic abnormalities
• 9. No significant hepatic abnormalities
• 10. No significant renal abnormalities
• 11. Female participants must have a negative serum pregnancy test prior to Study Day 1
• 12. All participants must be willing to follow the contraceptive guidance in the protocol
• 13. Absence of gross blood in stool at Screening
• 14. Participant must be willing to discontinue use of non-steroidal anti-inflammatory agents (NSAIDs) prior to Study Day 1
• 1. No clinically significant laboratory abnormality, medical or psychiatric illness
• 2. Has had prior pelvic irradiation.
• 3. Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881
• 4. Has received treatment with other investigational agents prior to Study Day 1
• 5. Treatment with other FAP-directed drug therapy within 8 weeks of screening endoscopy (Part 2 only).
• 6. Is currently under treatment for desmoid tumors.
• 7. Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1
• 8. Use of strong CYP3A inhibitors or inducers prior to Study Day 1
• 9. History of an ongoing or newly diagnosed eye abnormality.
• 10. Cancer at screening endoscopy in GI tract (including stomach, duodenum, and colon/rectum/pouch) (Part 2 only).
• 11. Has a large polyp (\>1 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 the study
• 15. Has had major surgery prior to Study Day 1
• 16. Has an active infection requiring systemic therapy.
• 17. Has known hypersensitivity to the study drug or its excipients.
• 18. History of alcohol or substance abuse.
• 19. Received treatment with another MEK inhibitor prior to Screening
• 20. Active or known HIV, hepatitis B or hepatitis C infections
• 21. Has a severe or uncontrolled medical condition
• 22. Use of strong BCRP or MRP2 inhibitors prior to Study Day 1
• 23. Has clinically significant cardiovascular disease within 6 months of Day 1 including myocardial infarction or unstable angina, cardiac arrhythmias, uncontrolled hypertension, pulmonary embolism, QTcF prolongation, Congestive heart failure, Myocarditis or clinically significant pericarditis