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New hope for Tough-to-Treat colorectal cancer: drug targets specific protein

NCT ID NCT06614192

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests two different doses of an investigational drug called telisotuzumab adizutecan in about 74 adults with metastatic colorectal cancer that has stopped responding to standard treatments and whose tumors have a specific protein (c-Met). The drug is given by IV infusion. Researchers will monitor side effects, tumor shrinkage, and overall survival to find the best dose.

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 provide a new treatment option for people with advanced colorectal cancer that has not responded to other therapies.
What could go wrong
This is an early-stage dose-finding study with only 74 participants, so results may not apply to all patients. The drug may cause side effects and may not shrink tumors or extend survival.

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

74 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Aug 2027

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: * Life expectancy \>= 12 weeks per investigator assessment. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Exclusion Criteria: * Prior systemic regimen containing c-MET targeting antibody/bispecific or Antibody Drug Conjugate (c-Met targeting Antibody Drug Conjugate \[ADC\]). * History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. * Active infection as noted in the protocol.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm

As listed by the trial registrant

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

Metastatic colorectal cancer

Contacts and locations

Locations

  • AdventHealth Orlando /ID# 267970

    Orlando, Florida, 32803, United States

  • Aichi Cancer Center /ID# 268237

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center /ID# 268717

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Assuta Medical Center - Tel Aviv /ID# 267745

    Tel Aviv, Tel Aviv, 6789140, Israel

  • Avera Cancer Institute - Sioux Falls /ID# 268074

    Sioux Falls, South Dakota, 57105, United States

  • Changhua Christian Hospital /ID# 270464

    Changhua City, Changhua County, 50006, Taiwan

  • China Medical University Hospital /ID# 267631

    Taichung, 40447, Taiwan

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655

    Irvine, California, 92618, United States

  • City of Hope National Medical Center /ID# 267875

    Duarte, California, 91010, United States

  • Community Cancer Center North /ID# 267965

    Indianapolis, Indiana, 46250, United States

  • Duke University Medical Center /ID# 267966

    Durham, North Carolina, 27710, United States

  • Hadassah Medical Center-Hebrew University /ID# 267579

    Jerusalem, 91120, Israel

  • Hattiesburg Clinic /ID# 267860

    Hattiesburg, Mississippi, 39401, United States

  • Hope And Healing Cancer Services /ID# 268541

    Hinsdale, Illinois, 60521, United States

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185

    Billings, Montana, 59102, United States

  • Kaohsiung Chang Gung Memorial Hospital /ID# 267638

    Kaohsiung City, 833, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635

    Kaohsiung City, 807, Taiwan

  • Linkou Chang Gung Memorial Hospital /ID# 267637

    Taoyuan City, 333, Taiwan

  • Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175

    Golden, Colorado, 80401, United States

  • Mater Hospital Brisbane /ID# 268360

    South Brisbane, Queensland, 4101, Australia

  • Millennium Physicians /ID# 268400

    Houston, Texas, 77090, United States

  • National Cancer Center Hospital /ID# 268713

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 268236

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital /ID# 270468

    Tainan, 704, Taiwan

  • National Taiwan University Hospital /ID# 267627

    Taipei, 100, Taiwan

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610

    Chicago, Illinois, 60611, United States

  • Pan American Center for Oncology Trials - Rio Piedras /ID# 267888

    Rio Piedras, 00935, Puerto Rico

  • Rabin Medical Center. /ID# 267740

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus- Haifa /ID# 267739

    Haifa, 3109601, Israel

  • Rutgers Cancer Institute of New Jersey /ID# 268056

    New Brunswick, New Jersey, 08901, United States

  • Saitama Prefectural Cancer Center /ID# 268706

    Kitaadachi-gun, Saitama, 362-0806, Japan

  • Samsung Medical Center /ID# 268720

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital /ID# 268592

    Seongnam-si, Gyeonggido, 13620, South Korea

  • Seoul National University Hospital /ID# 268719

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Springfield Clinic - First /ID# 268666

    Springfield, Illinois, 62702, United States

  • St. Luke's Cancer Institute: Boise /ID# 268095

    Boise, Idaho, 83712, United States

  • Taichung Veterans General Hospital /ID# 270467

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital /ID# 267628

    Taipei, 112, Taiwan

  • Tel Aviv Sourasky Medical Center /ID# 267578

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Chaim Sheba Medical Center /ID# 267741

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The University of Osaka Hospital /ID# 268743

    Suita-shi, Osaka, 565-0871, Japan

  • The University of Texas MD Anderson Cancer Center /ID# 268098

    Houston, Texas, 77030, United States

  • USC Norris Comprehensive Cancer Center /ID# 268131

    Los Angeles, California, 90033, United States

  • University of North Carolina Medical Center /ID# 266879

    Chapel Hill, North Carolina, 27514, United States

  • University of Texas - Southwestern Medical Center /ID# 268241

    Dallas, Texas, 75235, United States

  • University of Virginia /ID# 268108

    Charlottesville, Virginia, 22908, United States

  • Washington University /ID# 267872

    St Louis, Missouri, 63110, United States

  • West Cancer Center and Research Institute - Germantown /ID# 268619

    Germantown, Tennessee, 38138, United States

  • Winship Cancer Institute of Emory University /ID# 266884

    Atlanta, Georgia, 30322, United States

  • Yale University School of Medicine /ID# 269125

    New Haven, Connecticut, 06510, United States

  • Yonsei University Health System Severance Hospital /ID# 268718

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

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