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: June 1, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Non-small Cell Lung 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:
December 31, 2027

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Slade Health Inward goods

    Mount Kuring-Gai, New South Wales 2080
    Australia

    Site Not Available

  • Alfred Health

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Peter MacCallum Cancer Center

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Peter MacCallum Cancer Center

    North Melbourne, Victoria 3051
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Site Not Available

  • Linear Clinical Research Limited

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • CHU de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • 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

    Site Not Available

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

    Porto Alegre, PA 90035-903
    Brazil

    Active - Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná 81520-060
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará 90035-903
    Brazil

    Site Not Available

  • Universidade de Caxias do Sul

    Caxias Do Sul, RS 95070-561
    Brazil

    Active - Recruiting

  • Universidade de Caxias do Sul

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

    Site Not Available

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

    Porto Alegre, Rio Grande do Sul 90610-000
    Brazil

    Site Not Available

  • Hospital de Cancer de Barretos

    Barretos, SP 14784-400
    Brazil

    Active - Recruiting

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

    Sao Jose Do Rio Preto, SP 15090-000
    Brazil

    Active - Recruiting

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    Sao Paulo, SP 01246-000
    Brazil

    Site Not Available

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

    São José do Rio Preto, São Paulo 15090-000
    Brazil

    Site Not Available

  • Instituto Nacional de Câncer

    Rio de Janeiro, 20230-130
    Brazil

    Site Not Available

  • Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Jewish General Hospital; Sir Mortimer B. Davis

    Montreal, Quebec H2W 1S6
    Canada

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Site Not Available

  • Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088
    Hungary

    Site Not Available

  • Clinexpert Kft. - Gyongyos

    Gyongyos, 3200
    Hungary

    Active - Recruiting

  • Clinexpert Gyongyos Kft

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Sheba Medical Center - PPDS

    Ramat-Gan, 5262000
    Israel

    Active - Recruiting

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • 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;Oncologia Medica

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, Lombardy 20162
    Italy

    Site Not Available

  • Irccs Ospedale San Raffaele

    Milan, Lombardy 20132
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy 20089
    Italy

    Site Not Available

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan 3173435, Lombardy 3174618 20162
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany 56100
    Italy

    Site Not Available

  • Aga Khan University Hospital

    Nairobi, 30270-00100
    Kenya

    Active - Recruiting

  • The Aga Khan University-Kenya.

    Nairobi, 00100
    Kenya

    Site Not Available

  • Aga Khan University Hospital

    Nairobi 184745, 00100
    Kenya

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center - PPDS

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • 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

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Auckland City Hospital

    Auckland,
    New Zealand

    Site Not Available

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023
    New Zealand

    Site Not Available

  • Auckland City Hospital

    Auckland 2193733,
    New Zealand

    Site Not Available

  • New Zealand Clinical Research - Christchurch

    Christchurch,
    New Zealand

    Site Not Available

  • Haukeland University Hospital

    Bergen, 5020
    Norway

    Site Not Available

  • Haukeland University Hospital; Hospital Pharmacy

    Bergen, 5053
    Norway

    Active - Recruiting

  • Oslo university hospital Radiumhospitalet

    Oslo, 0424
    Norway

    Site Not Available

  • Medical University of Gdansk

    Gdansk, 80-952
    Poland

    Active - Recruiting

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

    Gdansk, 80-214
    Poland

    Site Not Available

  • Biokinetica, Przychodnia Jozefow

    Jozefow, 05-410
    Poland

    Active - Recruiting

  • Biokinetica, Przychodnia Jozefow

    Józefów, 05-410
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Pozna?, 60-780
    Poland

    Active - Recruiting

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

    Kazan, Tatarstan 420029
    Russian Federation

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605
    South Korea

    Site Not Available

  • Asan Medical Center - PPDS

    Seoul, 05505
    South Korea

    Site Not Available

  • Samsung Medical Center - PPDS

    Seoul, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Site Not Available

  • Asan Medical Center - PPDS

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro-CIOCC

    Madrid, 28050
    Spain

    Site Not Available

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, 41013
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Universitaetsspital Basel; Onkologie

    Basel, 4031
    Switzerland

    Site Not Available

  • Inselspital

    Bern, 3010
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève

    Geneva, 1211
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève

    Genève, 1211
    Switzerland

    Active - Recruiting

  • Unversitätsspital Zürich

    Zürich, 8091
    Switzerland

    Active - Recruiting

  • Queen Elizabeth Hospital

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Velindre Cancer Centre

    Cardiff, CF14 2TL
    United Kingdom

    Site Not Available

  • University College London - PPDS

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • 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

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • UCSD Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center UCI

    Orange, California 92868
    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

    Site Not Available

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 11101
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Oklahoma; Stephenson Oklahoma Canc Ctr

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Abramson Cancer Center; Univ of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UPMC - Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

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