If you have a disease called familial adenomatous polyposis, or FAP, you may be eligible to participate in a study to investigate the safety and efficacy of an investigational drug called REC-4881.

To be eligible, individuals (55 years of age or older) will have FAP and will already have had surgery to remove a portion of their large intestine (a colectomy).

There are two parts to the study: Part 1 and Part 2. Part 1, which is now complete, was aimed at assessing how someone's body processes REC-4881 (known as “pharmacokinetics” or “PK”). Part 2 includes two stages: Dose Finding and the Cohort Expansion. In the Dose Finding part, the safety and tolerability of REC-4881 will be explored in increasing dose levels of REC-4881. One or two dose levels which are found to be safe and tolerable during this part of testing will then be used in the second part of the study (the Cohort Expansion part) where we will continue to explore the safety and tolerability of the selected doses of REC-4881, as well as look at the effectiveness of these doses.
‍
Part 1 (enrollment complete)
Seven participants were enrolled and treated with a single dose and 14 daily doses of REC-4881 or placebo to evaluate the safety and PK/PD of REC-4481.

Part 2 (open now)
Part 2 is the larger part of the study and will enroll approximately 60 additional participants. It is open label and will consist of two Treatment Phases: Initial Treatment Phase and Treatment Extension Phase. Initial Treatment Phase will begin with the Dose Finding part before progressing to Cohort Expansion part. Dose Finding will follow a Bayesian Optimal Interval (BOIN) design with a targeted toxicity rate of 25%. Planned dose levels consist of 4 and 8mg cohorts in which REC-4881 will be administered once daily (QD). Following determination of Cohort Expansion dose(s), Dose Expansion will begin and continue to enroll approximately 24 additional participants at the select dose(s) for a total of 30 participants per dose level. This study will include a Futility Assessment after approximately 10 participants at the dose expansion dose(s) have had at least one on-treatment endoscopy.

‍If you are interested in participating, please visit clinicaltrials.gov and search for "REC-4881"