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New combo therapy aims to slow advanced GIST

NCT ID NCT05208047

Disease control Sponsor: Cogent Biosciences, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the experimental drug CGT9486 to the standard drug sunitinib helps people with advanced GIST live longer without their cancer growing. About 482 adults with GIST that cannot be removed by surgery or has spread will take part. The goal is to see if the combination works better than sunitinib alone.

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 482 people

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

Started

Apr 2022

Expected to finish

Jan 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.

Key Inclusion Criteria: 1. Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization. (GIST 1L Substudy: must have documented mutation in KIT Exon 9 with an available molecular pathology report; archival or fresh tumor tissue sample will be required) 2. Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy) 3. Subjects must have received the following treatment: * DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST * Part 1b: Treatment with ≥2 prior TKI for GISTs * Part 2: Prior treatment with imatinib only * GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 subjects with ongoing imatinib therapy of ≤4 weeks 4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy) 5. Eastern Cooperative Oncology Group (ECOG) Status * 0 to 2 (Part 1a, Part 1b, Part 2, DDI Substudy) * 0 to 1 (GIST 1L Substudy) 6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits Key Exclusion Criteria: 1. Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy) 2. Clinically significant cardiac disease 3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy) 4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption 5. Any active bleeding excluding hemorrhoidal or gum bleeding 6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody. 7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening 8. Received strong CYP3A4 inhibitors or inducers (Part 1a, Part 1b, Part 2, DDI Substudy) 9. Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)

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Conditions

The condition(s) this trial relates to.

gastrointestinal stromal tumor metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Advanced gastrointestinal stromal tumors Metastatic cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AP-HM - Hôpital de la Timone

    ACTIVE_NOT_RECRUITING

    Marseille, 13005, France

  • ASST degli Spedali Civili di Brescia

    ACTIVE_NOT_RECRUITING

    Brescia, 25123, Italy

  • Aarhus University Hospital

    ACTIVE_NOT_RECRUITING

    Aarhus, 8200, Denmark

  • Alberta Health Services Cross Cancer Institute

    ACTIVE_NOT_RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Asan Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

    ACTIVE_NOT_RECRUITING

    Verona, 31726, Italy

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    ACTIVE_NOT_RECRUITING

    Palermo, 90127, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    ACTIVE_NOT_RECRUITING

    Florence, 50134, Italy

  • Bankstown-Lidcombe Hospital

    ACTIVE_NOT_RECRUITING

    Bankstown, 2200, Australia

  • Beatson, West of Scotland Cancer Centre

    WITHDRAWN

    Glasgow, G12 0YN, United Kingdom

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    ACTIVE_NOT_RECRUITING

    São Paulo, 09060-650, Brazil

  • CHU de Toulouse - Hospital Rangueil

    ACTIVE_NOT_RECRUITING

    Toulouse, 31400, France

  • Cambridge Addenbrooke's Hospital

    ACTIVE_NOT_RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Centre Eugene Marquis

    ACTIVE_NOT_RECRUITING

    Rennes, 35042, France

  • Centre Leon Berard

    ACTIVE_NOT_RECRUITING

    Lyon, 69008, France

  • Centre Oscar Lambret

    ACTIVE_NOT_RECRUITING

    Lille, 59000, France

  • Centro Riferimento Oncologico - Aviano

    ACTIVE_NOT_RECRUITING

    Aviano, 33081, Italy

  • Centro de Investigacion Medica Aquascalientes (CIMA)

    WITHDRAWN

    Aguascalientes, 20116, Mexico

  • Centro de Oncologia de Precision, Universidad Mayor

    ACTIVE_NOT_RECRUITING

    Santiago, 7560908, Chile

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka

    WITHDRAWN

    Bydgoszcz, 85-796, Poland

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    ACTIVE_NOT_RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)

    ACTIVE_NOT_RECRUITING

    Taoyuan, 33305, Taiwan

  • China Medical University Hospital

    ACTIVE_NOT_RECRUITING

    Taichung, 40447, Taiwan

  • City of Hope

    ACTIVE_NOT_RECRUITING

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika

    ACTIVE_NOT_RECRUITING

    Debrecen, 4032, Hungary

  • Duke University

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27705, United States

  • Erasmus MC

    ACTIVE_NOT_RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fakultni nemocnice Hradec Kralove

    WITHDRAWN

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Olomouc - Oncology clinic

    ACTIVE_NOT_RECRUITING

    Olomouc, 77900, Czechia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    ACTIVE_NOT_RECRUITING

    Milan, 20133, Italy

  • Fox Chase Cancer Center

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    ACTIVE_NOT_RECRUITING

    Seattle, Washington, 98109, United States

  • Gustave Roussy

    ACTIVE_NOT_RECRUITING

    Villejuif, 94805, France

  • Guy's Hospital

    WITHDRAWN

    London, SE1 9RT, United Kingdom

  • Haukeland University Hospital - Bergen

    ACTIVE_NOT_RECRUITING

    Bergen, 5021, Norway

  • Helios Klinikum Bad Saarow

    ACTIVE_NOT_RECRUITING

    Bad Saarow, 15526, Germany

  • Helios Klinikum Berlin-Buch

    ACTIVE_NOT_RECRUITING

    Berlin, 13125, Germany

  • Hong Kong United Oncology Centre

    ACTIVE_NOT_RECRUITING

    Jordon, Hong Kong

  • Hospital Clinico San Carlos

    ACTIVE_NOT_RECRUITING

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Virgen de la Arrixaca

    WITHDRAWN

    El Palmar, 30120, Spain

  • Hospital Clinico Universitario de Santiago de Compostela

    ACTIVE_NOT_RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hospital Fundación Jiménez Díaz

    ACTIVE_NOT_RECRUITING

    Madrid, 28040, Spain

  • Hospital General Universitario Gregorio Maranon

    ACTIVE_NOT_RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre

    ACTIVE_NOT_RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Miguel Servet

    WITHDRAWN

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall d'Hebron

    ACTIVE_NOT_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    ACTIVE_NOT_RECRUITING

    Seville, 41013, Spain

  • Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)

    ACTIVE_NOT_RECRUITING

    Campinas, 130.83-888, Brazil

  • Hospital de la Santa Creu i Sant Pau Barcelona

    WITHDRAWN

    Barcelona, 08041, Spain

  • Humanity & Health Clinical Trial Centre

    WITHDRAWN

    Central, Hong Kong

  • I Can Oncology Center SA De CV

    ACTIVE_NOT_RECRUITING

    Monterrey, 64710, Mexico

  • ICO St-Herblain

    ACTIVE_NOT_RECRUITING

    Saint-Herblain, 44800, France

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

    ACTIVE_NOT_RECRUITING

    Bologna, 40138, Italy

  • IRCCS La Fondazione e l'Istituto di Candiolo

    WITHDRAWN

    Candiolo, 10060, Italy

  • Institut Bergonie

    ACTIVE_NOT_RECRUITING

    Bordeaux, 33076, France

  • Institut Catala d'Oncologia - L'Hospitalet

    ACTIVE_NOT_RECRUITING

    Barcelona, 08908, Spain

  • Instituto Alexander Fleming

    ACTIVE_NOT_RECRUITING

    Buenos Aires, C1426ANZ, Argentina

  • Instituto Oncologico FALP

    ACTIVE_NOT_RECRUITING

    Santiago, 7500921, Chile

  • Instituto Oncologico de Cordoba (IONC)

    ACTIVE_NOT_RECRUITING

    Córdoba, X5000HWE, Argentina

  • Istituto Clinico Humanitas

    ACTIVE_NOT_RECRUITING

    Rozzano, 20089, Italy

  • Istituto Europeo di Oncologia

    ACTIVE_NOT_RECRUITING

    Milan, 20141, Italy

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    ACTIVE_NOT_RECRUITING

    Meldola, 47014, Italy

  • Karolinska University Hospital

    ACTIVE_NOT_RECRUITING

    Solna, 171 76, Sweden

  • Korea University Guro Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, 08308, South Korea

  • Masarykuv onkologicky ustav

    ACTIVE_NOT_RECRUITING

    Brno, 65653, Czechia

  • Mayo Clinic

    ACTIVE_NOT_RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    ACTIVE_NOT_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Jacksonville

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32224, United States

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Medizinische Hochschule Hannover- Urology Oncology

    ACTIVE_NOT_RECRUITING

    Hanover, 30625, Germany

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Mid Florida Hematology and Oncology Center

    WITHDRAWN

    Orange City, Florida, 32763, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

    ACTIVE_NOT_RECRUITING

    Warsaw, 02-781, Poland

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej

    ACTIVE_NOT_RECRUITING

    Gliwice, 44-102, Poland

  • National Cancer Center

    WITHDRAWN

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

  • National Taiwan University Hospital

    ACTIVE_NOT_RECRUITING

    New Taipei City, 10002, Taiwan

  • Nebraska Methodist Hospital

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

    ACTIVE_NOT_RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oaxaca Site Management Organization S.C.

    WITHDRAWN

    Oaxaca City, 68000, Mexico

  • Oregon Health & Science University (OHSU)

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97239, United States

  • Orlando Health Cancer Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Oslo University Hospital

    ACTIVE_NOT_RECRUITING

    Oslo, 0310, Norway

  • Policlinico Universitario Campus Bio-Medico

    ACTIVE_NOT_RECRUITING

    Roma, 00128, Italy

  • Prince of Wales Hospital

    ACTIVE_NOT_RECRUITING

    Shatin, Hong Kong

  • Princess Margaret Hospital

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Roswell Park Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Buffalo, New York, 14203, United States

  • Royal Marsden Hospital - Surrey

    ACTIVE_NOT_RECRUITING

    London, SW3 6JJ, United Kingdom

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hosptial

    ACTIVE_NOT_RECRUITING

    Seoul, 03080, South Korea

  • Sheffield Teaching Hospitals NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Sheffield, S10 2SJ, United Kingdom

  • Sir Charles Gairdner Hospital

    ACTIVE_NOT_RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Skane University Hospital Lund

    ACTIVE_NOT_RECRUITING

    Lund, 22185, Sweden

  • Stichting Radboud Universitair Medisch Centrum

    ACTIVE_NOT_RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Szpital Specjalistyczny w Brzozowie

    ACTIVE_NOT_RECRUITING

    Brzozów, 36-200, Poland

  • Taipei Veterans General Hospital (VGHTP)

    ACTIVE_NOT_RECRUITING

    Taipei, 11217, Taiwan

  • The Christie NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Cleveland Clinic Foundation

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Ohio State University Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Texas MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030-4009, United States

  • Tom Baker Cancer Center

    ACTIVE_NOT_RECRUITING

    Calgary, T2N 4N2, Canada

  • UMC Groningen

    ACTIVE_NOT_RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Universitaetsklinikum Essen

    ACTIVE_NOT_RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Hamburg-Eppendorf

    ACTIVE_NOT_RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsmedizin Mannheim

    ACTIVE_NOT_RECRUITING

    Mannheim, 68167, Germany

  • Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)

    ACTIVE_NOT_RECRUITING

    Montreal, HIT 2M4, Canada

  • University College London Hospital

    ACTIVE_NOT_RECRUITING

    London, NW1 2PG, United Kingdom

  • University of Alabama at Birmingham

    WITHDRAWN

    Birmingham, Alabama, 35249, United States

  • University of Arizona- Cancer Center

    ACTIVE_NOT_RECRUITING

    Tucson, Arizona, 85719, United States

  • University of California, Los Angeles (UCLA)

    ACTIVE_NOT_RECRUITING

    Los Angeles, California, 90404, United States

  • University of California, San Diego (UCSD)

    ACTIVE_NOT_RECRUITING

    San Diego, California, 92093, United States

  • University of California, San Francisco

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94158, United States

  • University of Colorado Denver

    ACTIVE_NOT_RECRUITING

    Denver, Colorado, 80204, United States

  • University of Iowa Hospital and Clinics

    ACTIVE_NOT_RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center

    ACTIVE_NOT_RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Tennessee

    WITHDRAWN

    Knoxville, Tennessee, 37920, United States

  • University of Toledo Medical Center

    WITHDRAWN

    Toledo, Ohio, 43614, United States

  • University of Wisconsin - Carbone Cancer Center

    ACTIVE_NOT_RECRUITING

    Madison, Wisconsin, 53705, United States

  • Vanderbilt University Medical Center

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63130, United States

  • lnstituto Nacional de Cancer - INCA

    ACTIVE_NOT_RECRUITING

    Rio de Janeiro, 20.230-130, Brazil

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