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New drug combo aims to shrink Hard-to-Treat colorectal tumors

NCT ID NCT06820463

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 15, 2026 · Updated 22 times

Summary

This study tests an experimental drug called telisotuzumab adizutecan combined with standard chemotherapy in people whose colorectal cancer has spread. The goal is to see if the combination shrinks tumors and is safe. About 390 adults will take part at hospitals worldwide.

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 (an investigational antibody-drug conjugate) combined with standard chemotherapy drugs (FOLFOX, 5FU, leucovorin, bevacizumab, or panitumumab)
What this could lead to
If successful, this could offer a new treatment option for people with metastatic colorectal cancer that has spread and is hard to treat.
What could go wrong
This is an early Phase 2 trial, so the drug may not work better than current treatments. Side effects from the combination could be significant, and the study will take about 6 years to complete.

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 390 people

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

Started

Apr 2025

Expected to finish

Apr 2028

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: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Laboratory values meeting the criteria within the protocol. * Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1. Exclusion Criteria: * Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan). * History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.

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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.

Metastatic 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

    71 sites in 14 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

  • AdventHealth Orlando /ID# 270789

    RECRUITING

    Orlando, Florida, 32803, United States

  • Aichi Cancer Center /ID# 270113

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Arthur J.E Child Comprehensive Cancer Centre /ID# 269809

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Austin Health /ID# 270692

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Barts Health NHS Trust /ID# 271189

    RECRUITING

    London, Greater London, E1 2ES, United Kingdom

  • Centre Hospitalier Universitaire de Poitiers /ID# 270225

    RECRUITING

    Poitiers, New Aquitaine, 86021, France

  • Chu De Lille - Hopital Claude Huriez /ID# 270222

    RECRUITING

    Lille, Hauts-de-France, 59037, France

  • City of Hope National Medical Center /ID# 270255

    RECRUITING

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra - Madrid /ID# 269754

    RECRUITING

    Madrid, 28027, Spain

  • Cross Cancer Institute. /ID# 272711

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana-Farber Cancer Institute /ID# 270624

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fakultni Thomayerova nemocnice /ID# 269632

    RECRUITING

    Prague, Praha, Hlavni Mesto, 140 59, Czechia

  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 268773

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Motol a Homolka /ID# 268776

    RECRUITING

    Prague, Praha 5, 150 06, Czechia

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Hadassah Medical Center-Hebrew University /ID# 268007

    RECRUITING

    Jerusalem, 91120, Israel

  • Hope And Healing Cancer Services /ID# 271562

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Hopital Europeen Georges Pompidou /ID# 270224

    RECRUITING

    Paris, 75015, France

  • Hospital Clinico Universitario de Valencia /ID# 269805

    RECRUITING

    Valencia, 46010, Spain

  • Hospital De Amor /ID# 271874

    RECRUITING

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital Sao Rafael /ID# 271681

    RECRUITING

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Hospital Universitario Marques de Valdecilla /ID# 269732

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Vall de Hebron /ID# 270191

    RECRUITING

    Barcelona, 08035, Spain

  • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 270546

    RECRUITING

    São Paulo, 01401-002, Brazil

  • Kaohsiung Chang Gung Memorial Hospital /ID# 269726

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 268874

    RECRUITING

    Salzburg, 5020, Austria

  • Linkou Chang Gung Memorial Hospital /ID# 269725

    RECRUITING

    Taoyuan City, 333, Taiwan

  • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270680

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Macquarie University /ID# 271514

    RECRUITING

    Sydney, New South Wales, 2109, Australia

  • Masarykuv onkologicky ustav v Brne /ID# 268779

    RECRUITING

    Brno, 656 53, Czechia

  • Mater Misericordiae /ID# 270694

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Medizinische Universitaet Wien /ID# 268872

    RECRUITING

    Vienna, 1090, Austria

  • National Cancer Center Hospital /ID# 270112

    RECRUITING

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 270114

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital /ID# 270835

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital /ID# 269717

    RECRUITING

    Taipei, 100, Taiwan

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Northwest Georgia Oncology Centers /ID# 270245

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Nucleo De Pesquisa Clinica Da Rede Sao Camilo /ID# 272311

    RECRUITING

    São Paulo, 04014-002, Brazil

  • Oncology Hematology Care - Eastgate /ID# 271493

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147

    RECRUITING

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • One Clinical Research /ID# 270695

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Oxford University Hospitals Nhs Foundation Trust /ID# 272486

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Pan American Center for Oncology Trials - Rio Piedras /ID# 268809

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Princess Margaret Cancer Centre /ID# 268715

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Puerto Rico Medical Research Center /ID# 268825

    RECRUITING

    San Juan, 00917-5022, Puerto Rico

  • Rabin Medical Center. /ID# 268008

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus- Haifa /ID# 268006

    RECRUITING

    Haifa, 3109601, Israel

  • Saint Lukes Hospital of Kansas City /ID# 270633

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Shaare Zedek Medical Center /ID# 268009

    RECRUITING

    Jerusalem, 9103102, Israel

  • St Marianna University School Of Medicine /ID# 270111

    RECRUITING

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • St. Luke's Hospital /ID# 269963

    RECRUITING

    Panórama, Thessaloniki, 55236, Greece

  • Taipei Veterans General Hospital /ID# 269718

    RECRUITING

    Taipei, 112, Taiwan

  • Tel Aviv Sourasky Medical Center /ID# 268010

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Texas Oncology - Austin Midtown /ID# 271354

    RECRUITING

    Austin, Texas, 78705, United States

  • Texas Oncology - Deke Slayton Cancer Center /ID# 271355

    RECRUITING

    Webster, Texas, 77598, United States

  • The Christie NHS Foundation Trust - Christie Hospital /ID# 271561

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Queen Elizabeth Hospital /ID# 270693

    RECRUITING

    Woodville South, South Australia, 5011, Australia

  • The Royal Marsden - Sutton /ID# 271172

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Theagenio Cancer Hospital /ID# 269640

    RECRUITING

    Thessaloniki, 54639, Greece

  • Tohoku University Hospital /ID# 270966

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

  • UCLA - Santa Monica /ID# 270621

    RECRUITING

    Santa Monica, California, 90404, United States

  • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 271368

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • University Of Michigan /ID# 270790

    RECRUITING

    Ann Arbor, Michigan, 48109-5000, United States

  • University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 271298

    RECRUITING

    Seattle, Washington, 98109, United States

  • University of Chicago Medical Center /ID# 271688

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of North Carolina Medical Center /ID# 267786

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • Virginia Cancer Specialists - Fairfax /ID# 271351

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Vseobecna Fakultni nemocnice v Praze /ID# 268775

    RECRUITING

    Prague, Praha 17, 128 00, Czechia

  • Yale New Haven Hospital /ID# 270565

    RECRUITING

    New Haven, Connecticut, 06510, United States

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