A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Last updated: April 11, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Colorectal Cancer

Colon Cancer

Rectal Cancer

Treatment

Bevacizumab

Erlotinib

GDC-1971

Clinical Study ID

NCT04449874
GO42144
2020-000084-22
2023-506311-18-00
  • Ages > 18
  • All Genders

Study Summary

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically documented advanced or metastatic solid tumor with KRAS G12Cmutation.

  • Women of childbearing potential must agree to remain abstinent or use contraception,and agree to refrain from donating eggs during the treatment period and after thefinal dose of study treatment as specified in the protocol.

  • Men who are not surgically sterile must agree to remain abstinent or use a condom,and agreement to refrain from donating sperm during the treatment period and afterthe final dose of study treatment as specified in the protocol.

Exclusion

Exclusion Criteria:

  • Active brain metastases.

  • Malabsorption or other condition that interferes with enteral absorption.

  • Clinically significant cardiovascular dysfunction or liver disease.

Study Design

Total Participants: 498
Treatment Group(s): 7
Primary Treatment: Bevacizumab
Phase: 1
Study Start date:
July 29, 2020
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Slade Health Inward goods

    Mount Kuring-gai, New South Wales 2080
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Alfred Health

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    North Melbourne, Victoria 3051
    Australia

    Site Not Available

  • Linear Clinical Research Limited

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • CHU de Liège

    Herstal, 4040
    Belgium

    Site Not Available

  • CHU de Liège

    Liège, 4000
    Belgium

    Active - Recruiting

  • AZ St Maarten Campus Leopoldstr

    Mechelen, 2800
    Belgium

    Site Not Available

  • Santa Casa de Misericórdia de Belo Horizonte - PPDS

    Belo Horizonte, MG 30150-221
    Brazil

    Active - Recruiting

  • Santa Casa de Misericordia de Belo Horizonte - PPDS

    Belo Horizonte, Minas Gerais 30150-221
    Brazil

    Completed

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    Porto Alegre, PA 90035-903
    Brazil

    Active - Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná 81520-060
    Brazil

    Completed

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará 90035-903
    Brazil

    Active - Recruiting

  • Universidade de Caxias do Sul

    Caxias Do Sul, Rio Grande Do Sul 95070-561
    Brazil

    Active - Recruiting

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Completed

  • Hospital de Cancer de Barretos

    Barretos, São Paulo 14784-400
    Brazil

    Completed

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

    Sao Jose Do Rio Preto, São Paulo 15090-000
    Brazil

    Active - Recruiting

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    Sao Paulo, São Paulo 01246-000
    Brazil

    Site Not Available

  • Instituto Nacional de Câncer

    Rio de Janeiro, 20230-130
    Brazil

    Active - Recruiting

  • Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Completed

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Jewish General Hospital; Sir Mortimer B. Davis

    Montreal, Quebec H2W 1S6
    Canada

    Active - Recruiting

  • Centre Georges Francois Leclerc

    Dijon, 21000
    France

    Site Not Available

  • Centre Leon Berard

    Lyon, 69008
    France

    Site Not Available

  • CIC-CPCET; CIC - CPCET - Batiment F - 1er étage

    Marseille, 13385
    France

    Site Not Available

  • Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

    Rennes, 35000
    France

    Site Not Available

  • EDOG - Institut Claudius Regaud - PPDS

    Toulouse, 31000
    France

    Site Not Available

  • Institut Gustave Roussy; Departement Oncologie Medicale

    Villejuif, 94805
    France

    Site Not Available

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Clinical Research Center (CRC) Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376
    Germany

    Site Not Available

  • Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie

    Köln, 50931
    Germany

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1083
    Hungary

    Site Not Available

  • Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088
    Hungary

    Site Not Available

  • Clinexpert Kft. - Gyongyos

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Clinexpert Gyongyos Kft

    Gyöngyös, 3200
    Hungary

    Suspended

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Sheba Medical Center - PPDS

    Ramat-Gan, 5262000
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

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

    Meldola, Emilia-Romagna 47014
    Italy

    Site Not Available

  • Asst Grande Ospedale Metropolitano Niguarda

    Milano, Lombardia 20162
    Italy

    Site Not Available

  • Irccs Ospedale San Raffaele

    Milano, Lombardia 20132
    Italy

    Completed

  • Irccs Ospedale San Raffaele;Oncologia Medica

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardia 20089
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Toscana 56100
    Italy

    Site Not Available

  • Aga Khan University Hospital

    Nairobi, 00100
    Kenya

    Completed

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center - PPDS

    Seoul, 05505
    Korea, Republic of

    Completed

  • Samsung Medical Center - PPDS

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center

    Maastricht, 6229 HX
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Auckland City Hospital

    Auckland,
    New Zealand

    Active - Recruiting

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research - Christchurch

    Christchurch,
    New Zealand

    Active - Recruiting

  • Haukeland University Hospital

    Bergen, 5020
    Norway

    Completed

  • Haukeland University Hospital; Hospital Pharmacy

    Bergen, 5053
    Norway

    Active - Recruiting

  • Oslo university hospital Radiumhospitalet

    Oslo, 0424
    Norway

    Active - Recruiting

  • Medical University of Gdansk

    Gdansk, 80-952
    Poland

    Active - Recruiting

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

    Gdansk, 80-214
    Poland

    Active - Recruiting

  • Biokinetica, Przychodnia Jozefow

    Jozefow, 05-410
    Poland

    Completed

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Pozna?, 60-780
    Poland

    Site Not Available

  • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

    Poznań, 60-780
    Poland

    Site Not Available

  • Russian Oncology Research Center n a N N Blokhin

    Moscow, Moskovskaja Oblast 115478
    Russian Federation

    Site Not Available

  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

    Kazan, Tatarstan 420029
    Russian Federation

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro-CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Universitaetsspital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • Universitaetsspital Basel; Onkologie

    Basel, 4031
    Switzerland

    Site Not Available

  • Inselspital

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaires de Genève

    Genève, 1211
    Switzerland

    Active - Recruiting

  • Unversitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL
    United Kingdom

    Active - Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • UCSD Moores Cancer Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Chao Family Comprehensive Cancer Center UCI

    Orange, California 92868
    United States

    Completed

  • Univ of Calif, San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • Univ of Calif, San Francisco; Breast Cancer Center

    San Francisco, California 94115
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Rush University Medical Center - PPDS

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Completed

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • University of Oklahoma; Stephenson Oklahoma Canc Ctr

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Abramson Cancer Center; Univ of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UPMC - Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Completed

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