What type of study is this?

This is a Pre-Registered Trial study.

What question did this study set out to answer?

This research aims to assess the safety and tolerability of ONC201 in individuals at high risk for colorectal cancer.

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Phase I trial evaluates safety of ONC201 for chemoprevention in colorectal adenomas, suggesting potential benefit for high-risk populations.

This research aims to assess the safety and tolerability of ONC201 in individuals at high risk for colorectal cancer.
Phase I open-label trial
Participants with familial adenomatous polyposis or multiple colorectal adenomas
Doses of ONC201 administered weekly or every 3 weeks
Monitoring for unacceptable toxicity and TRAIL expression changes
Enrollment across multiple U.S. academic centers
Primary endpoint measures unacceptable toxicity in participants receiving ONC201
Secondary endpoints include changes in TRAIL expression in adenomas
Exploratory endpoints focus on cytokine changes and markers of cell behavior in tissue samples.

Raufi et al. (2026) studied this question.

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Phase I trial evaluates safety of ONC201 for chemoprevention in colorectal adenomas, suggesting potential benefit for high-risk populations.