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New hope for Tough-to-Treat colon cancer: experimental drug combo enters final testing

NCT ID NCT07549412

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This Phase 3 trial tests a new drug called precemtabart tocentecan, alone or with bevacizumab, against a standard treatment for metastatic colorectal cancer that has progressed after prior therapies. About 1,020 participants will be randomly assigned to one of three treatment groups. The main goal is to see if the new drug helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
precemtabart tocentecan (a drug), bevacizumab, and trifluridine/tipiracil
What this could lead to
If successful, this could offer a new treatment option for people with metastatic colorectal cancer who have already tried standard therapies, potentially extending survival.
What could go wrong
This is a large Phase 3 trial, but the experimental drug is still unproven. It may not improve survival or could cause side effects. Results may take years.

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 1,020 people

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

Started

May 2026

Expected to finish

Oct 2029

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: * Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting. * Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting * Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1 * Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations * Other protocol defined inclusion criteria may apply Exclusion Criteria: * If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0 * Participant has a history of additional malignancy within 3 years before randomization * Participants with known brain metastases * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization * Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments * Other protocol defined exclusion criteria may apply

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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

    66 sites in 16 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

  • Aberdeen Royal Infirmary - Dept of Oncology

    RECRUITING

    Aberdeen, Grampian Region, AB25 2ZN, United Kingdom

  • Asan Medical Center

    RECRUITING

    Seoul, 138-736, South Korea

  • Blue Ridge Cancer Care - 300202915

    RECRUITING

    Roanoke, Virginia, 24014-2419, United States

  • CHU Saint Etienne - Hôpital Nord - Service de Gastro-Entérologie et Hépatologie

    RECRUITING

    Saint Priest En Jarez, Pays de la Loire Region, 42270, France

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Kōtoku, Tokyo-To, 135-8550, Japan

  • Centre Leon Berard - Service d'Oncologie Medicale

    RECRUITING

    Lyon, Rhone, 69008, France

  • Centro Oncologico de Excelencia

    RECRUITING

    San Juan, 5400, Argentina

  • Centro de Investigaciones Medicas Tucuman

    RECRUITING

    San Miguel de Tucumán, T4000AXL, Argentina

  • China Medical University Hospital

    RECRUITING

    Taichung, 40447, Taiwan

  • Cliniques Universitaires Saint-Luc - STL

    RECRUITING

    Brussels, 1200, Belgium

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Florida Cancer Specialists - St. Petersburg Bayfront

    RECRUITING

    St. Petersburg, Florida, 33701-4553, United States

  • Florida Cancer Specialists East - FCS EAST - West Palm Beach

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists-Broadway

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • GenesisCare North Shore (Oncology)

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Grand Hospital de Charleroi - PARENT

    RECRUITING

    Charleroi, 6000, Belgium

  • Groupe Hospitalier Pitie-Salpetriere - Service Hépato-Gastro-Entérologie

    RECRUITING

    Paris, 75013, France

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi Zhuang, 530021, China

  • Hopital Claude Huriez - CHU Lille - service d'oncologie medicale

    RECRUITING

    Lille, Nord, 59037, France

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    RECRUITING

    Madrid, 28034, Spain

  • Icon Cancer Centre Chermside

    RECRUITING

    Chermside, Queensland, 4032, Australia

  • Illinois Cancer Specialists

    RECRUITING

    Arlington Heights, Illinois, 60005, United States

  • Illinois CancerCare PC

    RECRUITING

    Peoria, Illinois, 61615-7822, United States

  • Instituto de Oncologia de Rosario

    RECRUITING

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Investigaciones Clinicas Moleculares ICM

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1417DTB, Argentina

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Kanagawa Cancer Center - Dept of Gastroenterology

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Kindai University Hospital

    RECRUITING

    Sakai-shi, Osaka, 590-0197, Japan

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 08308, South Korea

  • Krankenhaus Nordwest GmbH - Neurologische Klinik

    RECRUITING

    Frankfurt am Main, Hesse, 60488, Germany

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Daegu, Gyeongsangnam-do, 700-721, South Korea

  • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

    RECRUITING

    Salzburg, 5020, Austria

  • Mater Misericordiae Ltd - PARENT

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Minnesota Oncology Hematology, P.A.

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Missouri Cancer Associates - 150518964

    RECRUITING

    Columbia, Missouri, 65201, United States

  • NHO Kyushu Cancer Center - 300175822

    RECRUITING

    Fukuoka, Fukuoka, 811-1395, Japan

  • National Cancer Center

    RECRUITING

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital

    RECRUITING

    Chūōku, Tokyo-To, 104-0045, Japan

  • Profound Research LLC at Cancer and Leukemia Center

    RECRUITING

    Sterling Heights, Michigan, 48098, United States

  • Rocky Mountain Cancer Centers, LLP- Aurora

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • SP ZOZ Szpital Uniwersytecki w Krakowie - Dept of Clinical Oncology and Oncology Clinic

    RECRUITING

    Krakow, 31-501, Poland

  • Saitama Cancer Center - 300175812

    RECRUITING

    Kitaadachi-gun, Saitama, 362-0806, Japan

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

    RECRUITING

    Seoul, 03722, South Korea

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Springfield Clinic

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

  • Texas Oncology DFW

    RECRUITING

    Bedford, Texas, 75246, United States

  • Texas Oncology, P.A. - Abilene - 300210366

    RECRUITING

    Abilene, Texas, 79606, United States

  • Texas Oncology, P.A. - Tyler

    RECRUITING

    Tyler, Texas, 75702, United States

  • Texas Oncology- San Antonio

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Texas Oncology-South Austin

    RECRUITING

    Austin, Texas, 78745, United States

  • The Catholic University of Korea, Seoul St. Maryâ

    RECRUITING

    Seoul, 06591, South Korea

  • The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)

    RECRUITING

    Hong Kong, 00000, Hong Kong

  • The Christie Hospital - Dept of Oncology

    RECRUITING

    Manchester, Great Manchester, M20 4BX, United Kingdom

  • The Ottawa Hospital Cancer Centre

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430060, China

  • University Health Network - Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Virginia Oncology Associates

    RECRUITING

    Newport News, Virginia, 23606, United States

  • White Plains Hospital Medical and Wellness PRIME

    RECRUITING

    White Plains, New York, 10601, United States

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