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New drug aims to stop colorectal cancer recurrence in patients with hidden tumor DNA

NCT ID NCT07023289

Disease control Sponsor: AbbVie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether the investigational drug telisotuzumab adizutecan can prevent colorectal cancer from coming back in patients who have no visible tumors but still have cancer DNA in their blood after surgery. About 140 adults will be randomly assigned to receive either the new drug or standard care. The study will track how long patients stay cancer-free and monitor side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
telisotuzumab adizutecan (ABBV-400)
What this could lead to
If successful, this could offer a new treatment option to prevent colorectal cancer from returning in patients with signs of residual disease after surgery.
What could go wrong
This is a phase 2 trial with only 140 participants, so results may not apply to everyone. The drug is investigational and may cause side effects or fail to improve outcomes compared to current care.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 140 people

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

Started

Sep 2025

Expected to finish

Nov 2029

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: * Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum. * Surgical tumor material should be available for Signatera ctDNA personalized panel design. * Must have received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy. * Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing. * Circulating tumor deoxyribonucleic acid (ctDNA) positive within 1 year either after the end of adjuvant therapy or after tumor resection in subjects who are receiving neoadjuvant therapy and begin treatment within 6 weeks after ctDNA positivity is confirmed (reported). * For participants with rectal cancer a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet must have been administered. Please note that short course radiation or long-course chemoradiation does not count towards this 3-month minimum of platinum-doublet perioperative and/or adjuvant therapy. Exclusion Criteria: * No availability of surgical tissue sample. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm neoplasm

As listed by the trial registrant

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

Colorectal cancer

How to take part

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

  1. The places running it

    48 sites in 8 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Aarhus Universitetshospital - Skejby /ID# 274498

    RECRUITING

    Aarhus, Central Jutland, 8200, Denmark

  • Abramson Cancer Center at the University of Pennsylvania /ID# 275407

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Aichi Cancer Center /ID# 275479

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center /ID# 274454

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540

    RECRUITING

    Naples, Napoli, 80138, Italy

  • Azienda Ospedaliero Universitaria Careggi /ID# 273604

    RECRUITING

    Florence, Firenze, 50134, Italy

  • CHU de Liege /ID# 278857

    RECRUITING

    Liège, 4000, Belgium

  • China Medical University Hospital /ID# 274644

    RECRUITING

    Taichung, 40447, Taiwan

  • Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621

    RECRUITING

    Huntsville, Alabama, 35805, United States

  • Cliniques Universitaires UCL Saint-Luc /ID# 278669

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Duke University Medical Center /ID# 279457

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Gifu University Hospital /ID# 274179

    RECRUITING

    Gifu, Gifu, 501-1194, Japan

  • Hospital Universitario La Paz /ID# 273718

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocio /ID# 273720

    RECRUITING

    Seville, Sevilla, 41013, Spain

  • Hospital Universitario de Salamanca /ID# 273719

    RECRUITING

    Salamanca, 37007, Spain

  • IRCCS Istituto Clinico Humanitas /ID# 273566

    RECRUITING

    Rozzano, Lombardy, 20089, Italy

  • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Johns Hopkins Hospital /ID# 275645

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Kyushu University Hospital /ID# 273710

    RECRUITING

    Fukuoka, Fukuoka, 812-8582, Japan

  • Massachusetts General Hospital /ID# 273608

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Hospital Jacksonville /ID# 274472

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic-Rochester /ID# 273508

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center /ID# 274372

    RECRUITING

    Tampa, Florida, 33612, United States

  • National Cancer Center Hospital East /ID# 273614

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Hospital Organization Osaka National Hospital /ID# 274306

    RECRUITING

    Osaka, Osaka, 540-0006, Japan

  • National Taiwan University Hospital /ID# 273580

    RECRUITING

    Taipei, 100, Taiwan

  • Northwell Health Center for Advanced Medicine. /ID# 275331

    RECRUITING

    Lake Success, New York, 11042, United States

  • Northwest Cancer Specialists /ID# 275151

    RECRUITING

    Portland, Oregon, 97227-1800, United States

  • Odense University Hospital /ID# 274970

    RECRUITING

    Odense C, Region Syddanmark, 5000, Denmark

  • Providence Medical Foundation - Fullerton /ID# 274207

    RECRUITING

    Fullerton, California, 92835-3826, United States

  • SCRI Oncology Partners /ID# 274522

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center /ID# 274452

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Scri Minnesota Oncology Hematology, P.A. /ID# 275149

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Seoul National University Hospital /ID# 274451

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shizuoka Cancer Center /ID# 275480

    RECRUITING

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Texas Oncology - Central/South Texas /ID# 275154

    RECRUITING

    Austin, Texas, 78705, United States

  • Texas Oncology-Grapevine /ID# 275155

    RECRUITING

    Grapevine, Texas, 76051, United States

  • The Center For Cancer And Blood Disorders /ID# 278512

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • The University of Texas MD Anderson Cancer Center /ID# 273539

    RECRUITING

    Houston, Texas, 77030, United States

  • Tohoku University Hospital /ID# 275481

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

  • USC Norris Comprehensive Cancer Center /ID# 274550

    RECRUITING

    Los Angeles, California, 90033, United States

  • Universitair Ziekenhuis Leuven /ID# 278668

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University of Chicago Medical Center /ID# 274742

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Michigan Health System - Ann Arbor /ID# 273511

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Vejle Sygehus /ID# 274368

    RECRUITING

    Vejle, Region Syddanmark, 7100, Denmark

  • Virginia Cancer Specialists - Fairfax /ID# 274339

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Yokohama City University Medical Center /ID# 273657

    RECRUITING

    Yokohama, Kanagawa, 232-0024, Japan

More trials for these conditions

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