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New drug eRapa could slow polyps in inherited colon cancer condition

NCT ID NCT06950385

Disease control Sponsor: Rapamycin Holdings Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if the drug eRapa can slow disease progression in adults with Familial Adenomatous Polyposis (FAP), a condition that causes many polyps in the gut and raises cancer risk. About 168 participants will take eRapa or a placebo daily every other week. Researchers will track how long it takes for the disease to worsen, using colonoscopies and other checks every 3 to 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must be ≥18 years of age inclusive. 2. Participant must have documented FAP, confirmed by adenomatous polyposis coli genotype mutation testing. 3. Participant must have at least 1 of the following high-risk features: \>100 polyps but ≤500 polyps in the colon, or ≥10 polyps in the retained rectum/sigmoid or ileal pouch (≥3 mm in size), or Spigelman stage 3 or 4 with at least 1 polyp ≥10 mm to be removed at baseline or on endoscopy performed within 18 months of screening. 4. Contraceptive use by participants or participant partners until at at least 12 weeks after stopping study treatment. 5. Agree not to donate gametes for the purpose of reproduction until at at least 12 weeks after stopping study treatment. 6. Willing to undergo endoscopic evaluation. Exclusion Criteria: 1. Participant has unresected or incompletely resected high-grade dysplasia or cancer within the duodenum, colon, rectum, or ileal pouch at screening endoscopy. 2. Participant has any polyps ≥8 mm in the duodenum, colon, rectum, or ileal pouch remaining after screening endoscopy (polyps ≥8 mm are to be resected during screening endoscopy). 3. Participant has had surgery within 6 weeks of the trial. 4. Participant has active malignancy or history of malignancy diagnosed within 24 months of first dose of trial intervention. 5. Participant has a history of, or currently has, an acquired or primary (congenital) immunodeficiency. 6. Participant has active and clinically significant tuberculosis (positive Quantiferon Gold test), bacterial, fungal, or viral infection, including human immunodeficiency virus (HIV). 7. Participant has any medical or social condition that, in the opinion of the Investigator, might increase participant risk if enrolled, prevent participant compliance to trial procedures, or present an unacceptable confound to safety or clinical trial data.

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Conditions

The condition(s) this trial relates to.

Adenomatous Polyposis Coli classic familial adenomatous polyposis polyp

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Familial adenomatous polyposis (FAP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    29 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

  • Benaroya Research Institute at Virginia Mason

    RECRUITING

    Seattle, Washington, 98101, United States

  • City of Hope

    RECRUITING

    Arcadia, California, 91007, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

  • Copenhagen University Hospital

    RECRUITING

    Copenhagen, Denmark

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Department of Surgery, Section of Colon Rectal and Surgery

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Digestive & Liver Center of Florida

    RECRUITING

    Orlando, Florida, 32825, United States

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

  • Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20057, United States

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Comarcal de Inca

    RECRUITING

    Inca, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Spain

  • Hospital La Fe de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Oncologico - Puerto Rico Medical Center

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Italy

  • Istituto Nazionale dei Tumori

    RECRUITING

    Milan, Italy

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

    Contact Email: •••••@•••••

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Radboud University Medical Center

    RECRUITING

    Nijmegen, Netherlands

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60615, United States

    Contact Email: •••••@•••••

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Washington - Fred Hutchinson

    RECRUITING

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, Germany

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.