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New hope for hard-to-treat colon cancer: targeted drug shrinks tumors

NCT ID NCT04744831

Disease control Sponsor: Daiichi Sankyo 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a drug called trastuzumab deruxtecan (T-DXd) in 122 people with advanced colorectal cancer that has too much HER2 protein. The goal was to see if the drug could shrink tumors. About 45% of patients had their tumors shrink. This treatment is not a cure, but it may help control the disease for a while.

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

122 people

The number who actually took part.

Started

Mar 2021

Finished

Dec 2024

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.

KEY Inclusion Criteria: Participants must meet all of the following criteria to be eligible for randomization/registration into the study: 1. Adults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed. 2. Pathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site. 3. The following therapies should be included in prior lines of therapy: 1. Fluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated 2. Anti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated 3. Anti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated 4. Anti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated 4. Confirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +. 5. Presence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 7. Has left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration. KEY Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: 1. Medical history of myocardial infarction (MI) within 6 months before randomization/registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal (ULN) at Screening (as defined by the manufacturer), and without any MI-related symptoms, should have a cardiologic consultation before randomization/registration to rule out MI. 2. Has a corrected QT interval corrected with Fridericia's formula (QTcF) prolongation to \>470 msec (female participants) or \>450 msec (male participants) based on the average of the Screening triplicate 12-lead electrocardiograms (ECGs). 3. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. 4. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the randomization/registration, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion, etc.). 5. Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren syndrome, sarcoidosis, etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of Screening. 6. Prior pneumonectomy. 7. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole-brain radiotherapy and randomization/registration. 8. Participants with leptomeningeal carcinomatosis. 9. Has known human immunodeficiency virus (HIV) infection. 10. Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days before study randomization/registration. Participants with past or resolved hepatitis B virus (HBV) infection are eligible if hepatitis B surface antigen (HBsAg) negative (-) and antibody to hepatitis B core antigen (anti-HBc) positive (+). Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). 11. Previous treatment with a DXd-containing antibody-drug conjugate (ADC).

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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.

Advanced colorectal cancer

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Aichi, Japan

  • Aienda Ospedaliera San Camillo Forlanini

    Rome, Italy

  • Asan Medical Center

    Seoul, South Korea

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Italy

  • Azienda ULSS 8 Berica

    Vicenza, Italy

  • Beatson Glasgow

    Glasgow, United Kingdom

  • Blacktown Hospital

    Blacktown, Australia

  • Centre Antoine Lacassagne

    Nice, France

  • Centre de Lutte Contre le Cancer CLCC - Institut Curie

    Saint-Cloud, France

  • Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

    Taoyuan, Taiwan

  • Chang Gung Memorial Hospital-LinKou

    Taoyuan, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

  • Chu Toulouse

    Toulouse, France

  • Clinica Universitaria de Navarra

    Pamplona, Spain

  • Clinica Universitaria de Navarra - Madrid

    Madrid, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Flinders Medical Centre (FMC)

    Bedford Park, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • Hokkaido University Hospital

    Hokkaido, Japan

  • Hopital Edouard Herriot

    Lyon, France

  • Hopital Jean Minjoz

    Besançon, France

  • Hopital St Antoine

    Paris, France

  • Hospital Clinico y Provincial de Barcelona

    Barcelona, Spain

  • Hospital Universitari Vall dHebron

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • ICM-Val d'Aurelle

    Montpellier, France

  • Istituto Oncologico Veneto Irccs

    Padova, Italy

  • Kanagawa Cancer Center

    Kanagawa, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital KMUH

    Kaohsiung City, Taiwan

  • Kindai University Hospital

    Osaka, Japan

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center (MSKCC)

    New York, New York, 10065, United States

  • Monash Medical Centre

    Clayton, Australia

  • National Cancer Center (NCC)

    Goyang-si, South Korea

  • National Cancer Center Hospital

    Tokyo, Japan

  • National Cancer Center Hospital East

    Chiba, Japan

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, Japan

  • National Hospital Organization Shikoku Cancer Center

    Ehime, Japan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Norton Cancer Institute Audubon

    Louisville, Kentucky, 40217, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Australia

  • Royal Brisbane & Women's Hospital

    Brisbane, Australia

  • Samsung Medical Center

    Seoul, South Korea

  • Sarah Cannon (Tennessee Oncology - Nashville)

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    Gyeonggi-do, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

  • The Cancer Institute Hospital of JFCR

    Tokyo, Japan

  • The Christie

    Manchester, United Kingdom

  • The Royal Marsden Hospital

    London, United Kingdom

  • The Royal Marsden Hospital

    Sutton, United Kingdom

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCL St-Luc

    Brussels, Belgium

  • UCLH Trust

    London, United Kingdom

  • UZ Antwerpen

    Edegem, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • University Hospital of nantes

    Nantes, France

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

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