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New study matches colorectal cancer patients to precision drugs

NCT ID NCT04929223

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study tests the safety and effectiveness of targeted therapies or immunotherapies in people with metastatic colorectal cancer (cancer that has spread). Participants are assigned to a treatment based on specific biomarkers found in their tumor. The goal is to see if these personalized treatments can shrink tumors or slow disease progression.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 542 people

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

Started

Oct 2021

Expected to finish

Aug 2030

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 * Signed cohort-specific Informed Consent Form * Age \>= 18 years at time of signing Informed Consent Form * Biomarker eligibility as determined by: * A validated test approved by local health authorities for detection of the specified biomarkers/mutations. * A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers. * Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR * Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 1 * Life expectancy \>= 3 months, as determined by the investigator * Histologically confirmed adenocarcinoma originating from the colon or rectum * Metastatic disease * Prior therapies for metastatic disease * Ability to comply with the study protocol, in the investigators judgment * Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research * Adequate hematologic and organ function within 14 days prior to initiation of study treatment * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures * For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria * Current participation or enrollment in another interventional clinical trial. Participants who are participating in the follow-up period of an interventional clinical trial are eligible for the study. * Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Pregnant or breastfeeding, or intending to become pregnant during the study * History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study * Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety * Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) * Uncontrolled tumor-related pain * Uncontrolled or symptomatic hypercalcemia * Clinically significant and active liver disease * Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months. * Symptomatic, untreated, or actively progressing CNS metastases * History of leptomeningeal disease or carcinomatous meningitis * History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications * Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher risk for treatment-related complications

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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

    62 sites in 10 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

  • Addenbrookes Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, 22763, Germany

  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

    RECRUITING

    Milan, Lombardy, 20162, Italy

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Charité Universitätsmedizin Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Jeollanam-do, 58128, South Korea

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Duke University Medical Center

    COMPLETED

    Durham, North Carolina, 27710, United States

  • Eastern Ct Hema/Onco Assoc

    WITHDRAWN

    Norwich, Connecticut, 06360, United States

  • Hematology Oncology Salem

    RECRUITING

    Salem, Oregon, 97301, United States

  • Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed

    RECRUITING

    Herlev, 2730, Denmark

  • Hoag Memorial Hospital Presbyterian

    WITHDRAWN

    Newport Beach, California, 92663, United States

  • Hospital Clinico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario de Donostia

    RECRUITING

    Donostia / San Sebastian, Guipuzcoa, 20080, Spain

  • IRCCS Istituto Oncologico Veneto (IOV)

    RECRUITING

    Padova, Veneto, 35128, Italy

  • Illinois Cancer Specialists

    RECRUITING

    Arlington Heights, Illinois, 60005, United States

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, W2 1NY, United Kingdom

  • Irccs Istituto Nazionale Dei Tumori (Int)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

    RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

  • Jewish General Hospital

    WITHDRAWN

    Montreal, Quebec, H3T 1E2, Canada

  • Karmanos Cancer Institute

    WITHDRAWN

    Detroit, Michigan, 48201, United States

  • Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital

    RECRUITING

    Bochum, 44791, Germany

  • Klinikum der Universität München, Campus Großhadern

    WITHDRAWN

    München, 81377, Germany

  • Lumi Research

    WITHDRAWN

    Kingwood, Texas, 77339, United States

  • Mary Bird Perkins Cancer Ctr

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Massachusetts General Hospital

    COMPLETED

    Boston, Massachusetts, 02114-2621, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85259, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • McGill University Health Center

    WITHDRAWN

    Montreal, Quebec, H4A 3J1, Canada

  • Medical Oncology Associates

    WITHDRAWN

    Spokane, Washington, 99208, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

    SUSPENDED

    Warsaw, 02-781, Poland

  • National Cancer Center

    RECRUITING

    Goyang-si, 10408, South Korea

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 00704, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Zhongzheng Dist., 10048, Taiwan

  • New York Cancer & Blood Specialists

    RECRUITING

    Port Jefferson Station, New York, 11776, United States

  • New York Cancer & Blood Specialists - Bronx

    RECRUITING

    The Bronx, New York, 10469-5930, United States

  • New York Cancer & Blood Specialists - New Hyde Park

    RECRUITING

    New Hyde Park, New York, 11042-1116, United States

  • New York Cancer and Blood Specialists-Central Park Hematology & Oncology

    RECRUITING

    New York, New York, 10028, United States

  • Peter Maccallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, Lazio, 00168, Italy

  • Princess Margaret Cancer Center

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

  • Rigshospitalet, Onkologisk Klinik

    COMPLETED

    København Ø, 2100, Denmark

  • Rocky Mountain Cancer Centers, LLP

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • Royal Free Hospital

    WITHDRAWN

    London, NW3 2QG, United Kingdom

  • Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Royal Marsden Hospital;Dept of Med-Onc

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III

    RECRUITING

    Heilbronn, 74078, Germany

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • START Madrid. Centro Integral Oncologico Clara Campal

    WITHDRAWN

    Madrid, 28050, Spain

  • Samsung Medical Center

    RECRUITING

    Seoul, (0)6351, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Sarah Cannon Research Institute / Tennessee Oncology

    COMPLETED

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, 13605, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Stanford Cancer Center

    COMPLETED

    Stanford, California, 94305-5820, United States

  • Swedish Cancer Inst.

    COMPLETED

    Seattle, Washington, 98104, United States

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    SUSPENDED

    Krakow, 30-688, Poland

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

  • Texas Oncology - Gulf Coast

    RECRUITING

    Webster, Texas, 77598-4420, United States

  • Texas Oncology - Northeast Texas

    RECRUITING

    Denton, Texas, 76201, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • UAB Comprehensive Cancer Center

    WITHDRAWN

    Birmingham, Alabama, 35233, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UPMC - Hillman Cancer Center

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • USC Norris Cancer Center

    COMPLETED

    Los Angeles, California, 90033, United States

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Università degli Studi della Campania Luigi Vanvitelli

    RECRUITING

    Naples, Campania, 80131, Italy

  • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 60-569, Poland

  • Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz

    RECRUITING

    Gdansk, 80-952, Poland

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    RECRUITING

    Barcelona, 08035, Spain

  • Vanderbilt University Medical Center

    COMPLETED

    Nashville, Tennessee, 37232, United States

  • Velindre Cancer Centre

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

  • cCare

    WITHDRAWN

    Encinitas, California, 92024, United States

More trials for these conditions

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