Plain-English translation of NCT05630794 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing a medication called ONC201 to see if it can help prevent colorectal cancer in people who are at high risk—like those with a family history of the disease or who have had multiple polyps removed. Researchers want to understand whether this medication is safe and whether it can change how polyps develop in your colon. You would take the medication by mouth once a week or once every three weeks for 13 weeks while doctors monitor your health and take tissue samples.
People with certain conditions, like familial adenomatous polyposis or a history of multiple polyps, have a very high risk of developing colorectal cancer. Right now, doctors mainly watch these patients closely and remove polyps when they find them. This trial is exploring whether this medication might help prevent polyps from forming or progressing in the first place.
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You would take the medication by mouth either once per week or once every three weeks for 13 weeks total. During the study, you would have blood drawn multiple times, undergo colonoscopy or sigmoidoscopy procedures to examine and biopsy your colon, and have tissue samples collected. After finishing the 13-week treatment period, you would have a follow-up visit about three weeks later to make sure you are doing well.
AI-generated summary from trial data · Jun 15, 2026 · Not medical advice
United States