RecruitingPhase 1/2

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

United States67 participantsStarted 2023-07-10

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. Has any clinically significant 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.
✕. Has had prior pelvic irradiation.
✕. Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881, including difficulty swallowing capsules.
✕. 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.
✕. 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.
✕. Is currently under treatment for desmoid tumors.
✕. Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1
✕. Use of strong cytochrome P3A (CYP3A) inhibitors or inducers prior to Study Day 1

What they're measuring

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

Timeframe: Day 1 through Day 43

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

Timeframe: Day 1 through Day 43

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

Timeframe: Day 1 through Day 43

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

Timeframe: Day 1 through up to Week 37

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

Timeframe: First 28 days of treatment

Part 2: Number of Participants Who Discontinued Treatment

Timeframe: Day 1 through up to Week 37

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

Timeframe: Day 1 through up to Week 37

Part 2: Percent Change From Baseline in Polyp Burden

Trial details

NCT IDNCT05552755

SponsorRecursion Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Recursion Pharmaceuticals

385-374-1724 clinicaltrials@recursion.com

View on ClinicalTrials.gov More Familial Adenomatous Polyposis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. Has any clinically significant 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.
✕. Has had prior pelvic irradiation.
✕. Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881, including difficulty swallowing capsules.
✕. 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.
✕. 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.
✕. Is currently under treatment for desmoid tumors.
✕. Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1
✕. Use of strong cytochrome P3A (CYP3A) inhibitors or inducers prior to Study Day 1

What they're measuring

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

Timeframe: Day 1 through Day 43

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

Timeframe: Day 1 through Day 43

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

Timeframe: Day 1 through Day 43

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

Timeframe: Day 1 through up to Week 37

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

Timeframe: First 28 days of treatment

Part 2: Number of Participants Who Discontinued Treatment

Timeframe: Day 1 through up to Week 37

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

Timeframe: Day 1 through up to Week 37

Part 2: Percent Change From Baseline in Polyp Burden