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Recruiting nowPhase 3Ages 18 Years and up

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Sponsor: Cogent Biosciences, Inc. · NCT05208047 on ClinicalTrials.gov ↗

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Conditions studied

Advanced Gastrointestinal Stromal TumorsMetastatic Cancer

What it tests

  • CGT9486drug
  • CGT9486drug
  • Sunitinibdrug
  • Sunitinibdrug
  • Midazolamdrug
  • CGT9486drug
  • Sunitinibdrug
  • CGT9486drug
  • Sunitinibdrug

Where it's running126 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama 35249

    Withdrawn

  • Mayo Clinic

    Scottsdale, Arizona 85259

    Active, not recruiting

  • University of Arizona- Cancer Center

    Tucson, Arizona 85719

    Active, not recruiting

  • City of Hope

    Duarte, California 91010

    Active, not recruiting

  • University of California, Los Angeles (UCLA)

    Los Angeles, California 90404

    Active, not recruiting

  • University of California, San Diego (UCSD)

    San Diego, California 92093

    Active, not recruiting

  • University of California, San Francisco

    San Francisco, California 94158

    Active, not recruiting

  • University of Colorado Denver

    Denver, Colorado 80204

    Active, not recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia 20010

    Recruiting now

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224

    Active, not recruiting

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida 33136

    Recruiting now

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763

    Withdrawn

  • Orlando Health Cancer Institute

    Orlando, Florida 32806

    Recruiting now

  • Moffitt Cancer Center

    Tampa, Florida 33612

    Recruiting now

  • Northwestern University

    Chicago, Illinois 60611

    Recruiting now

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa 52242

    Active, not recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas 66160

    Active, not recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115

    Active, not recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109

    Active, not recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905

    Active, not recruiting

  • Washington University

    St Louis, Missouri 63130

    Recruiting now

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114

    Recruiting now

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021

    Recruiting now

  • Duke University

    Durham, North Carolina 27705

    Active, not recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195

    Active, not recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210

    Active, not recruiting

  • University of Toledo Medical Center

    Toledo, Ohio 43614

    Withdrawn

  • Oregon Health & Science University (OHSU)

    Portland, Oregon 97239

    Active, not recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111

    Active, not recruiting

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232

    Active, not recruiting

  • University of Tennessee

    Knoxville, Tennessee 37920

    Withdrawn

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232

    Active, not recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030-4009

    Active, not recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109

    Active, not recruiting

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin 53705

    Active, not recruiting
90 international sites

  • Instituto Alexander Fleming

    Buenos Aires, Argentina C1426ANZ

    Active, not recruiting

  • Instituto Oncologico de Cordoba (IONC)

    Córdoba, Argentina X5000HWE

    Active, not recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, Australia 6009

    Active, not recruiting

  • Bankstown-Lidcombe Hospital

    Bankstown, Australia 2200

    Active, not recruiting

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

    Campinas, Brazil 130.83-888

    Active, not recruiting

  • lnstituto Nacional de Cancer - INCA

    Rio de Janeiro, Brazil 20.230-130

    Active, not recruiting

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

    São Paulo, Brazil 09060-650

    Active, not recruiting

  • Alberta Health Services Cross Cancer Institute

    Edmonton, Alberta, Canada T6G 1Z2

    Active, not recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, Canada M5G 2M9

    Active, not recruiting

  • Tom Baker Cancer Center

    Calgary, Canada T2N 4N2

    Active, not recruiting

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

    Montreal, Canada HIT 2M4

    Active, not recruiting

  • Instituto Oncologico FALP

    Santiago, Chile 7500921

    Active, not recruiting

  • Centro de Oncologia de Precision, Universidad Mayor

    Santiago, Chile 7560908

    Active, not recruiting

  • Masarykuv onkologicky ustav

    Brno, Czechia 65653

    Active, not recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Czechia 500 05

    Withdrawn

  • Fakultni nemocnice Olomouc - Oncology clinic

    Olomouc, Czechia 77900

    Active, not recruiting

  • Aarhus University Hospital

    Aarhus, Denmark 8200

    Active, not recruiting

  • Institut Bergonie

    Bordeaux, France 33076

    Active, not recruiting

  • Centre Oscar Lambret

    Lille, France 59000

    Active, not recruiting

  • Centre Leon Berard

    Lyon, France 69008

    Active, not recruiting

  • AP-HM - Hôpital de la Timone

    Marseille, France 13005

    Active, not recruiting

  • Centre Eugene Marquis

    Rennes, France 35042

    Active, not recruiting

  • ICO St-Herblain

    Saint-Herblain, France 44800

    Active, not recruiting

  • CHU de Toulouse - Hospital Rangueil

    Toulouse, France 31400

    Active, not recruiting

  • Gustave Roussy

    Villejuif, France 94805

    Active, not recruiting

  • Helios Klinikum Bad Saarow

    Bad Saarow, Germany 15526

    Active, not recruiting

  • Helios Klinikum Berlin-Buch

    Berlin, Germany 13125

    Active, not recruiting

  • Universitaetsklinikum Essen

    Essen, Germany 45147

    Active, not recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, Germany 20246

    Active, not recruiting

  • Medizinische Hochschule Hannover- Urology Oncology

    Hanover, Germany 30625

    Active, not recruiting

  • Universitaetsmedizin Mannheim

    Mannheim, Germany 68167

    Active, not recruiting

  • Humanity & Health Clinical Trial Centre

    Central, Hong Kong

    Withdrawn

  • Hong Kong United Oncology Centre

    Jordon, Hong Kong

    Active, not recruiting

  • Prince of Wales Hospital

    Shatin, Hong Kong

    Active, not recruiting

  • Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika

    Debrecen, Hungary 4032

    Active, not recruiting

  • Centro Riferimento Oncologico - Aviano

    Aviano, Italy 33081

    Active, not recruiting

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

    Bologna, Italy 40138

    Active, not recruiting

  • ASST degli Spedali Civili di Brescia

    Brescia, Italy 25123

    Active, not recruiting

  • IRCCS La Fondazione e l'Istituto di Candiolo

    Candiolo, Italy 10060

    Withdrawn

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Italy 50134

    Active, not recruiting

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

    Meldola, Italy 47014

    Active, not recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy 20133

    Active, not recruiting

  • Istituto Europeo di Oncologia

    Milan, Italy 20141

    Active, not recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Italy 90127

    Active, not recruiting

  • Policlinico Universitario Campus Bio-Medico

    Roma, Italy 00128

    Active, not recruiting

  • Istituto Clinico Humanitas

    Rozzano, Italy 20089

    Active, not recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

    Verona, Italy 31726

    Active, not recruiting

  • Centro de Investigacion Medica Aquascalientes (CIMA)

    Aguascalientes, Mexico 20116

    Withdrawn

  • I Can Oncology Center SA De CV

    Monterrey, Mexico 64710

    Active, not recruiting

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, Mexico 68000

    Withdrawn

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

    Amsterdam, Netherlands 1066 CX

    Active, not recruiting

  • UMC Groningen

    Groningen, Netherlands 9713 GZ

    Active, not recruiting

  • Stichting Radboud Universitair Medisch Centrum

    Nijmegen, Netherlands 6525 GA

    Active, not recruiting

  • Erasmus MC

    Rotterdam, Netherlands 3015 GD

    Active, not recruiting

  • Haukeland University Hospital - Bergen

    Bergen, Norway 5021

    Active, not recruiting

  • Oslo University Hospital

    Oslo, Norway 0310

    Active, not recruiting

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, Poland 36-200

    Active, not recruiting

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka

    Bydgoszcz, Poland 85-796

    Withdrawn

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

    Gliwice, Poland 44-102

    Active, not recruiting

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

    Warsaw, Poland 02-781

    Active, not recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, South Korea 10408

    Withdrawn

  • Seoul National University Hosptial

    Seoul, South Korea 03080

    Active, not recruiting

  • Asan Medical Center

    Seoul, South Korea 05505

    Active, not recruiting

  • Samsung Medical Center

    Seoul, South Korea 06351

    Active, not recruiting

  • Korea University Guro Hospital

    Seoul, South Korea 08308

    Active, not recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain 08035

    Active, not recruiting

  • Hospital de la Santa Creu i Sant Pau Barcelona

    Barcelona, Spain 08041

    Withdrawn

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, Spain 08908

    Active, not recruiting

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Spain 30120

    Withdrawn

  • Hospital General Universitario Gregorio Maranon

    Madrid, Spain 28007

    Active, not recruiting

  • Hospital Clinico San Carlos

    Madrid, Spain 28040

    Active, not recruiting

  • Hospital Fundación Jiménez Díaz

    Madrid, Spain 28040

    Active, not recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Spain 28041

    Active, not recruiting

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, Spain 15706

    Active, not recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, Spain 41013

    Active, not recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain 50009

    Withdrawn

  • Skane University Hospital Lund

    Lund, Sweden 22185

    Active, not recruiting

  • Karolinska University Hospital

    Solna, Sweden 171 76

    Active, not recruiting

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, Taiwan 83301

    Active, not recruiting

  • National Taiwan University Hospital

    New Taipei City, Taiwan 10002

    Active, not recruiting

  • China Medical University Hospital

    Taichung, Taiwan 40447

    Active, not recruiting

  • Taipei Veterans General Hospital (VGHTP)

    Taipei, Taiwan 11217

    Active, not recruiting

  • Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)

    Taoyuan, Taiwan 33305

    Active, not recruiting

  • Cambridge Addenbrooke's Hospital

    Cambridge, United Kingdom CB2 0QQ

    Active, not recruiting

  • Beatson, West of Scotland Cancer Centre

    Glasgow, United Kingdom G12 0YN

    Withdrawn

  • University College London Hospital

    London, United Kingdom NW1 2PG

    Active, not recruiting

  • Guy's Hospital

    London, United Kingdom SE1 9RT

    Withdrawn

  • Royal Marsden Hospital - Surrey

    London, United Kingdom SW3 6JJ

    Active, not recruiting

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom M20 4BX

    Active, not recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, United Kingdom S10 2SJ

    Active, not recruiting
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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)

Updated 2026-06-16 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.