OncoMatch/Clinical Trials/NCT05552755
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
Is NCT05552755 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies REC-4881 for familial adenomatous polyposis.
Treatment: REC-4881 — This is a multicenter, two-part trial in participants with FAP.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: APC mutation
Prior therapy
Must have received: colectomy or subtotal colectomy
Has undergone colectomy or subtotal colectomy
Cannot have received: pelvic irradiation
Has had prior pelvic irradiation.
Cannot have received: other investigational agents
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.
Cannot have received: other FAP-directed drug therapy (Balsalazide)
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.
Cannot have received: mitogen-activated protein kinase (MEK) inhibitor
Received treatment with another mitogen-activated protein kinase (MEK) inhibitor 8 weeks prior to Screening and throughout the treatment period of the study.
Lab requirements
Blood counts
WBC ≥ 3,000/mm³ (non-black populations); 2,700/mm³ (black populations); Platelet count ≥ 120,000/mm³; Hemoglobin ≥ 10.0 g/dL; No history of clinical coagulopathy.
Kidney function
serum creatinine ≤ 1.5 × ULN.
Liver function
Total bilirubin ≤ 1.5 × ULN (individuals with Gilbert syndrome may be enrolled); AST, ALT, ALP ≤ 2.0 × ULN.
Cardiac function
Left ventricular ejection fraction >50% on ECHO/MUGA; QTcF < 450 msec in men and <470 msec in women.
Have no significant cardiovascular abnormalities at Screening: Left ventricular ejection fraction >50% as determined on screening echocardiogram (ECHO)/ multi-gated acquisition (MUGA); QTcF < 450 msec in men and <470 msec in women. Have no significant hematopoietic abnormalities at Screening: WBC ≥ 3,000/mm³ (non-black populations); 2,700/mm³ (black populations); Platelet count ≥ 120,000/mm³; Hemoglobin ≥ 10.0 g/dL; No history of clinical coagulopathy. Have no significant hepatic abnormalities at Screening: Total bilirubin ≤ 1.5 × ULN (individuals with Gilbert syndrome may be enrolled); AST, ALT, ALP ≤ 2.0 × ULN. Have no significant renal abnormalities at Screening: serum creatinine ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic - Scottsdale · Scottsdale, Arizona
- Del Sol Research Management · Tucson, Arizona
- Medical Associates Research Group · San Diego, California
- GI Pros · Naples, Florida
- Digestive and Liver Center of Florida · Orlando, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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