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New combo aims to shrink Hard-to-Treat colon tumors

NCT ID NCT06107413

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug, ABBV-400, combined with standard treatments for people with advanced colorectal cancer that has spread and cannot be removed by surgery. About 280 adults who have already tried one prior treatment will receive different doses of ABBV-400 plus chemotherapy and a targeted therapy. The goal is to see if the combination can shrink tumors or slow cancer growth better than current options.

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 280 people

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

Started

Nov 2023

Expected to finish

Dec 2026

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: * Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC). * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy. Exclusion Criteria: * Harbor the BRAF V600E mutation. * dMMR+/MSI-H. * Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma neoplasm

As listed by the trial registrant

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

Unresectable/metastatic colorectal cancer

Contacts and locations

Locations

  • AZ-Delta /ID# 257084

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Aichi Cancer Center Hospital /ID# 257286

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center /ID# 257845

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Assuta Medical Center /ID# 267581

    Tel Aviv, 6789140, Israel

  • Atrium Health Levine Cancer Institute /ID# 258840

    Charlotte, North Carolina, 28204, United States

  • Avera Cancer Institute /ID# 257949

    Sioux Falls, South Dakota, 57105, United States

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 257785

    Berlin, 13353, Germany

  • Chonnam National University Hwasun Hospital /ID# 258366

    Hwasun-gun, Jeonranamdo, 58128, South Korea

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365

    Irvine, California, 92618, United States

  • City of Hope National Medical Center /ID# 257576

    Duarte, California, 91010, United States

  • Cliniques Universitaires UCL Saint-Luc /ID# 257081

    Brussels, Brussels Capital, 1200, Belgium

  • Community Health Network, Inc. /ID# 257078

    Indianapolis, Indiana, 46250-2042, United States

  • Comprehensive Cancer Centers of Nevada /ID# 257642

    Henderson, Louisiana, 89052, United States

  • Duke Cancer Institute /ID# 257236

    Durham, North Carolina, 27710, United States

  • Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601

    Fort Wayne, Indiana, 46804, United States

  • Hadassah /ID# 257088

    Jerusalem, Jerusalem, 91120, Israel

  • Highlands Oncology Group, PA /ID# 259424

    Springdale, Arkansas, 72762, United States

  • Hospital Clinico Universitario de Valencia /ID# 257385

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon /ID# 257387

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre /ID# 257384

    Madrid, 28041, Spain

  • Hospital Universitario HM Sanchinarro /ID# 258549

    Madrid, 28050, Spain

  • Hospital Universitario Miguel Servet /ID# 257388

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall de Hebron /ID# 257383

    Barcelona, 08035, Spain

  • Imelda Ziekenhuis /ID# 257082

    Bonheiden, Antwerpen, 2820, Belgium

  • Indiana University Melvin and Bren Simon Cancer Center /ID# 258789

    Indianapolis, Indiana, 46202-5116, United States

  • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448

    Fairfax, Virginia, 22031, United States

  • Institut Jules Bordet /ID# 257625

    Anderlecht, 1070, Belgium

  • Kaohsiung Chang Gung Memorial Hospital /ID# 257675

    Kaohsiung City, Kaohsiung, 833, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257637

    Kaohsiung City, 807, Taiwan

  • Kyoto University Hospital /ID# 257287

    Kyoto, Kyoto, 606-8507, Japan

  • Linkou Chang Gung Memorial Hospital /ID# 257640

    Taoyuan City, 333, Taiwan

  • MD Anderson Cancer Center /ID# 258713

    Houston, Texas, 77030, United States

  • Mayo Clinic - Rochester /ID# 257301

    Rochester, Minnesota, 55905-0001, United States

  • Mayo Clinic Arizona /ID# 262610

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Hospital Jacksonville /ID# 262609

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina /ID# 258486

    Charleston, South Carolina, 29425, United States

  • Meir Medical Center /ID# 257089

    Kfar Saba, Central District, 4428164, Israel

  • National Cancer Center Hospital /ID# 257284

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 257282

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital /ID# 257638

    Tainan, 704, Taiwan

  • National Taiwan University Hospital /ID# 257639

    Taipei City, Taipei, 100, Taiwan

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University, Knight Cancer Institute- /ID# 259190

    Portland, Oregon, 97239, United States

  • Rambam Health Care Campus /ID# 257344

    Haifa, 3109601, Israel

  • Samsung Medical Center /ID# 257571

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital /ID# 257493

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shaare Zedek Medical Center /ID# 259253

    Jerusalem, Jerusalem, 91031, Israel

  • Shizuoka Cancer Center /ID# 257288

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Taipei Veterans General Hosp /ID# 257636

    Taipei, 11217, Taiwan

  • Tel Aviv Sourasky Medical Center /ID# 257090

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Texas Oncology PA /ID# 257780

    Houston, Texas, 77090-3063, United States

  • The Chaim Sheba Medical Center /ID# 257312

    Ramat Gan, Tel Aviv, 5265601, Israel

  • UZ Gent /ID# 257083

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 257787

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 257782

    Hamburg, 20246, Germany

  • Universitaetsklinikum Tuebingen /ID# 258780

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsklinikum Ulm /ID# 257783

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Universitair Ziekenhuis Antwerpen /ID# 257080

    Edegem, Antwerpen, 2650, Belgium

  • Universitair Ziekenhuis Leuven /ID# 257079

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Universitatsklinikum Mannheim /ID# 257781

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • University of Illinois Hospital and Health Sciences System /ID# 257300

    Chicago, Illinois, 60607, United States

  • Virginia Cancer Specialists - Fairfax /ID# 257261

    Fairfax, Virginia, 22031, United States

  • Yale School of Medicine /ID# 257494

    New Haven, Connecticut, 06519, United States

  • Yonsei University Health System Severance Hospital /ID# 257492

    Seoul, 03722, South Korea

More trials for these conditions

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