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Personalized cancer attack: new trial matches drugs to tumor genes

NCT ID NCT04589845

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 3 times

Summary

This phase II trial tests whether giving cancer drugs based on a tumor's genetic makeup can help people with advanced solid tumors that cannot be removed by surgery or have spread. About 920 participants will receive a drug or drug combination tailored to their tumor's specific gene changes. The main goal is to see how many participants have their tumors shrink or disappear.

What this could mean

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

Active substance
Entrectinib (Rozlytrek) and other targeted therapies or immunotherapies
What this could lead to
If successful, this trial could show that matching cancer treatment to a tumor's genetic profile helps shrink or control advanced solid tumors that have not responded to standard therapy.
What could go wrong
This is an early-phase (phase II) trial with no control group, so results may not prove effectiveness. The drugs may cause side effects or stop working over time.

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 920 people

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

Started

Jan 2021

Expected to finish

Sep 2032

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy * Measurable disease as defined by RECIST v1.1, RANO, or INRC * Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants aged 16 to \< 18 years: Karnofsky score ≥ 50%; Participants aged \< 16 years: Lansky score ≥ 50% * For participants aged ≥ 18 and \< 18 years: adequate hematologic and end-organ function * Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment * Adequate recovery from most recent systemic or local treatment for cancer * Life expectancy ≥ 8 weeks * Ability to comply with the study protocol, in the investigator's judgment * For female participants of childbearing potential: Negative serum pregnancy test ≤ 14 days prior to initiating study treatment, agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of \< 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period * For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria * In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort Exclusion Criteria: * Current participation or enrollment in another therapeutic clinical trial * Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment * Whole brain radiotherapy within 14 days prior to start of study treatment * Stereotactic radiosurgery within 7 days prior to start 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 participant's safe participation in and completion of the study or confounds the ability to interpret data from the study * 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 * Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina * History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy * In addition to the general exclusion criteria above, in order to be enrolled in a treatment cohort of the study, participants must not meet any of the cohort-specific exclusion criteria

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumors

Contacts and locations

Locations

  • Alliance Cancer Specialists

    Horsham, Pennsylvania, 19044, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25100, Italy

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

    Siena, Tuscany, 53100, Italy

  • BC Cancer ? Vancouver

    Vancouver, British Columbia, V5Z 1J3, Canada

  • Barrett Cancer Center

    Cincinnati, Ohio, 45219, United States

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Beijing Children's Hospital, Capital Medical University

    Beijing, China

  • Cancer Treatment Centers of America

    Philadelphia, Pennsylvania, 19124, United States

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Chang Gung Memorial Hospital-Linkou

    Taoyuan County, 333, Taiwan

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027, Spain

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Clínica Onco Star - Rede D'Or

    São Paulo, São Paulo, 04543-000, Brazil

  • Consultants in Medical Oncology and Hematology

    Broomall, Pennsylvania, 19008, United States

  • Dipartimento di Scienze Pediatriche Adolescenza

    Turin, Piedmont, 10126, Italy

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061, China

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • GHdC Site Les Viviers

    Charleroi, 6060, Belgium

  • Georg-August-Uniklinik

    Göttingen, 37075, Germany

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001, Israel

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hoag Memorial Hospital

    Newport Beach, California, 92658, United States

  • Hong Kong Children's Hospital

    Hong Kong, Hong Kong

  • Hopital de la Timone

    Marseille, 13005, France

  • Horizon Oncology Research, Inc.

    Lafayette, Indiana, 47905, United States

  • Hospital A. C. Camargo

    São Paulo, São Paulo, 01509-010, Brazil

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009, Spain

  • Hospital Sant Joan De Deu

    Esplugues de Llobregas, Barcelona, 08950, Spain

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050, Brazil

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario la Fe

    Valencia, 46026, Spain

  • IPO do Porto

    Porto, 4200-072, Portugal

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inselspital, Klinik und Poliklinik für Medizinische Onkologie

    Bern, 3010, Switzerland

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Universitaire du Cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Institut de Cancerologie Gustave-Roussy (IGR)

    Villejuif, 94805, France

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana

    Billings, Montana, 59102, United States

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133, Italy

  • Istituto Nazionale Tumori di Milano

    Milan, Lombardy, 20133, Italy

  • Kaiser Permanente Los Angeles

    Los Angeles, California, 90027, United States

  • Kindai University Hospital

    Osaka, 589-8511, Japan

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010, Australia

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75230, United States

  • Maryland Hematology & Oncology. P.A.

    Silver Spring, Maryland, 20904, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 11101, United States

  • Metro-Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416, United States

  • Midwestern Regional Med Center

    Zion, Illinois, 60099, United States

  • Montefiore Einstein Center for Cancer Care

    The Bronx, New York, 10461, United States

  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

    Warsaw, 02-781, Poland

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Centre

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    Tainan, 00704, Taiwan

  • National Taiwan University Hospital

    Zhongzheng Dist., 10048, Taiwan

  • National University Hospital

    Singapore, 119228, Singapore

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242, United States

  • Ospedale Pediatrico Bambino Gesù - IRCCS

    Rome, Lazio, 00165, Italy

  • PanOncology Trials

    San Juan, 00935, Puerto Rico

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168, Italy

  • Praxis für Hämatologie, Onkologie und Palliativmedizin

    Mönchengladbach, 41066, Germany

  • Prince of Wales Hospital

    Shatin, Hong Kong

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Rabin MC

    Petah Tikva, 4941492, Israel

  • Rigshospitalet

    København Ø, 2100, Denmark

  • Royal Children's Hospital

    Parkville, Victoria, 3052, Australia

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

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

    Heilbronn, 74078, Germany

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • START Madrid. Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • Samsung Medical Center- Adult Site

    Seoul, 06351, South Korea

  • Samsung Medical Center- Pediatric Site

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital- Adult Site

    Seoul, 03080, South Korea

  • Seoul National University Hospital- Pediatric Site

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • Sourasky / Ichilov Hospital

    Tel Aviv, 6423906, Israel

  • St. Alphonsus

    Boise, Idaho, 83706, United States

  • St. Jude Children'S Research Hospital

    Memphis, Tennessee, 38105, United States

  • Taipei Veterans General Hospital

    Taipei, 112201, Taiwan

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology - Central South

    Austin, Texas, 78731, United States

  • Texas Oncology- Northeast Texas

    Tyler, Texas, 75702, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1H3, Canada

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • The West Clinic

    Germantown, Tennessee, 38138, United States

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • USC Norris Cancer Center

    Los Angeles, California, 90033, United States

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Uniklinik Essen

    Essen, 45122, Germany

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607, United States

  • University College London Hospital

    London, NW1 - 2PG, United Kingdom

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214, Poland

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

    Barcelona, 08035, Spain

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

    Barcelona, 08035, Spain

  • Virginia Cancer Specialists - Leesburg

    Leesburg, Pennsylvania, 20176, United States

  • West China Hospital - Sichuan University

    Chengdu, 610047, China

  • Western Regional Medical Center at Cancer Treatment Centers of America

    Goodyear, Arizona, 85338, United States

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092, China

  • Zhongshan Hospital Fudan Unvierstiy

    Shanghai, China

More trials for these conditions

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