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New hope for Tough-to-Treat colorectal cancer: phase 3 trial launches

NCT ID NCT07525206

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 26 times

Summary

This Phase 3 study tests a new drug, telisotuzumab adizutecan, combined with bevacizumab, against the standard treatment (LONSURF plus bevacizumab) in 700 adults with advanced colorectal cancer that has stopped responding to prior therapies. The goal is to see if the new combo shrinks tumors or helps people live longer. Participants will be randomly assigned to one of the two treatment groups and monitored for about 36 months.

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 plus bevacizumab
What this could lead to
If successful, this could offer a new treatment option for people with advanced colorectal cancer that has stopped responding to other therapies.
What could go wrong
This is an early-stage Phase 3 trial, so the new drug may not prove more effective or safer than the current standard. Side effects are possible, and results may not apply to all patients.

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 990 people

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

Started

May 2026

Expected to finish

Mar 2030

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: * Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator. * Life expectancy \>= 12 weeks per investigator assessment Exclusion Criteria: * Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC. * History of intolerance, allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. This also includes patients with known rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. * History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies. * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal 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

    73 sites in 9 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

  • AZ Maria Middelares /ID# 280141

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • AZ-Delta. /ID# 279329

    RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Asan Medical Center /ID# 282732

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Astera Cancer Care /ID# 279532

    RECRUITING

    East Brunswick, New Jersey, 08816-4096, United States

  • Athens Medical Center - Psychikon Branch /ID# 279134

    RECRUITING

    Athens, Attica, 11525, Greece

  • Beijing Friendship Hospital /ID# 279766

    RECRUITING

    Beijing, Beijing Municipality, 100050, China

  • Beijing Hospital No. 2 /ID# 279666

    RECRUITING

    Beijing, Beijing Municipality, 100006, China

  • Blue Ridge Cancer Care - Blacksburg /ID# 280115

    RECRUITING

    Blacksburg, Virginia, 24060, United States

  • CHA Bundang Medical Center /ID# 279589

    RECRUITING

    Seongnam, Gyeonggido, 13496, South Korea

  • Chi Mei Medical Center /ID# 279710

    RECRUITING

    Tainan, 71004, Taiwan

  • China-Japan Union Hospital /ID# 279801

    RECRUITING

    Changchun, Jilin, 130033, China

  • Chonnam National University Hwasun Hospital /ID# 279787

    RECRUITING

    Hwasun-gun, Jeonranamdo, 58128, South Korea

  • City Of Hope - Atlanta /ID# 280017

    RECRUITING

    Newnan, Georgia, 30265, United States

  • City Of Hope - Phoenix /ID# 279450

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • City of Hope National Medical Center /ID# 279449

    RECRUITING

    Duarte, California, 91010, United States

  • Cliniques Universitaires UCL Saint-Luc /ID# 279335

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Compass Oncology - Rose Quarter /ID# 280127

    RECRUITING

    Portland, Oregon, 97227, United States

  • Dong-A University Medical Center /ID# 279610

    RECRUITING

    Busan, Busan Gwang Yeogsi, 49201, South Korea

  • Duke University Medical Center /ID# 279322

    RECRUITING

    Durham, North Carolina, 27710, United States

  • E-Da Cancer Hospital /ID# 279745

    RECRUITING

    Kaohsiung City, 824, Taiwan

  • First Affiliated Hospital of Shanxi Medical University /ID# 279665

    RECRUITING

    Taiyuan, Shanxi, 030001, China

  • Gachon University Gil Medical Center /ID# 279592

    RECRUITING

    Incheon, Gyeonggido, 21565, South Korea

  • General Hospital Of Ningxia Medical University /ID# 279644

    RECRUITING

    Yinchuan, Ningxia, 750004, China

  • General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 279133

    RECRUITING

    Nea Kifissia, Attica, 14564, Greece

  • Grand Hopital de Charleroi - Les Viviers /ID# 279336

    RECRUITING

    Charleroi, Hainaut, 6280, Belgium

  • Guangxi Medical University Cancer Hospital /ID# 279707

    RECRUITING

    Nanning, Guangxi, 530021, China

  • Highlands Oncology Group - Springdale /ID# 279444

    RECRUITING

    Springdale, Arkansas, 72762, United States

  • Hospital Clinico Universitario de Valencia /ID# 279645

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon /ID# 279650

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre /ID# 279659

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario La Paz /ID# 279664

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet /ID# 279653

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall de Hebron /ID# 279651

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu i Sant Pau /ID# 279642

    RECRUITING

    Barcelona, 08041, Spain

  • Imelda Ziekenhuis /ID# 279333

    RECRUITING

    Bonheiden, Antwerpen, 2820, Belgium

  • Institut Jules Bordet /ID# 279406

    RECRUITING

    Anderlecht, Brussels Capital, 1070, Belgium

  • Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702

    RECRUITING

    Porto, 4200-072, Portugal

  • Interbalkan Medical Center Of Thessaloniki /ID# 279288

    RECRUITING

    Thessaloniki, 57001, Greece

  • Jinan Central Hospital /ID# 279705

    RECRUITING

    Jinan, Shandong, 250013, China

  • Kobe City Medical Center General Hospital /ID# 280233

    RECRUITING

    Kobe, Hyōgo, 650-0047, Japan

  • Moffitt Cancer Center /ID# 279325

    RECRUITING

    Tampa, Florida, 33612, United States

  • National Cancer Center Hospital East /ID# 279917

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Hospital Organization Shikoku Cancer Center /ID# 280224

    RECRUITING

    Matsuyama, Ehime, 791-0280, Japan

  • Northwell Health Center for Advanced Medicine. /ID# 279590

    RECRUITING

    Lake Success, New York, 11042, United States

  • Oncology Hematology Care - Blue Ash /ID# 280143

    RECRUITING

    Cincinnati, Ohio, 45252, United States

  • Osaka International Cancer Institute /ID# 281810

    RECRUITING

    Osaka, Osaka, 5418567, Japan

  • Rocky Mountain Cancer Centers - Aurora /ID# 280112

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Saint Lukes Hospital of Kansas City /ID# 279513

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Seoul National University Hospital /ID# 282730

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • St Marianna University School Of Medicine /ID# 279902

    RECRUITING

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • Sun Yat-Sen University Cancer Center /ID# 279670

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708

    RECRUITING

    New Taipei City, 235, Taiwan

  • Taipei Medical University Hospital /ID# 280607

    RECRUITING

    Taipei, Tainan, 110, Taiwan

  • Taipei Municipal Wan Fang Hospital /ID# 280285

    RECRUITING

    Taipei, 116, Taiwan

  • Texas Oncology - Abilene - Antilley Road /ID# 280120

    RECRUITING

    Abilene, Texas, 79606, United States

  • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The Catholic University Of Korea St. Vincent's Hospital /ID# 279675

    RECRUITING

    Suwon, Gyeonggido, 16247, South Korea

  • The Fourth Affiliated Hospital of China Medical University /ID# 279799

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • Theagenio Cancer Hospital /ID# 279129

    RECRUITING

    Thessaloniki, 54639, Greece

  • Tri-Service General Hospital - Neihu Branch /ID# 279768

    RECRUITING

    Taipei, 114, Taiwan

  • Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637

    RECRUITING

    Almada, Setúbal District, 2805-267, Portugal

  • Unidade Local de Saude de Loures-Odivelas /ID# 279636

    RECRUITING

    Loures, Lisbon District, 2674-514, Portugal

  • Unidade Local de Saude de Santa Maria /ID# 279624

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Unidade Local de Saude do Alto Ave, EPE /ID# 279703

    RECRUITING

    Guimarães, Braga District, 4835-044, Portugal

  • Union Hospital - Tongji Medical College /ID# 283649

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Universitair Ziekenhuis Antwerpen /ID# 279334

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Universitair Ziekenhuis Brussel /ID# 279535

    RECRUITING

    Jette, Brussels Capital, 1090, Belgium

  • Universitair Ziekenhuis Leuven /ID# 279330

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 280014

    RECRUITING

    Yvoir, Namur, 5530, Belgium

  • University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451

    RECRUITING

    Seattle, Washington, 98109, United States

  • University of Chicago Medical Center /ID# 279365

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Yale University School of Medicine /ID# 279373

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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