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: February 11, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Colorectal Cancer

Colon Cancer

Rectal Cancer

Treatment

Erlotinib

GDC-1971

Cetuximab

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: Erlotinib
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

  • St Vincent's Hospital Sydney

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • Slade Health Inward goods

    Mount Kuring-Gai 8348691, New South Wales 2155400 2080
    Australia

    Site Not Available

  • Peter MacCallum Cancer Center

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Alfred Health

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Peter MacCallum Cancer Center

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    North Melbourne, Victoria 3051
    Australia

    Site Not Available

  • Alfred Health

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Site Not Available

  • 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

  • Linear Clinical Research Limited

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Antwerpen

    Edegem 2799007, 2650
    Belgium

    Site Not Available

  • CHU de Liège

    Herstal, 4040
    Belgium

    Site Not Available

  • CHU de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • CHU de Liège

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • AZ St Maarten Campus Leopoldstr

    Mechelen, 2800
    Belgium

    Site Not Available

  • AZ St Maarten Campus Leopoldstr

    Mechelen 2791537, 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

  • Santa Casa de Misericordia de Belo Horizonte - PPDS

    Belo Horizonte 3470127, Minas Gerais 3457153 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 Erasto Gaertner

    Curitiba 3464975, Paraná 3455077 81520-060
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará 90035-903
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Pôrto Alegre 3391403, Pará 3393129 90035-903
    Brazil

    Site Not Available

  • 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

  • Universidade de Caxias do Sul

    Caxias do Sul 3466537, Rio Grande do Sul 3451133 95070-561
    Brazil

    Site Not Available

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

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90610-000
    Brazil

    Site Not Available

  • Hospital de Cancer de Barretos

    Barretos, São Paulo 14784-400
    Brazil

    Site Not Available

  • 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

    Site Not Available

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    Sao Paulo, São Paulo 01246-000
    Brazil

    Site Not Available

  • Hospital de Cancer de Barretos

    Barretos 3470451, São Paulo 3448433 14784-400
    Brazil

    Site Not Available

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

    São José do Rio Preto 3448639, São Paulo 3448433 15090-000
    Brazil

    Site Not Available

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo 3448439, São Paulo 3448433 01246-000
    Brazil

    Site Not Available

  • Instituto Nacional de Câncer

    Rio de Janeiro, 20230-130
    Brazil

    Site Not Available

  • Instituto Nacional de Câncer

    Rio de Janeiro 3451190, 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

  • Ottawa Hospital

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 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

  • Jewish General Hospital

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Site Not Available

  • 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

  • Semmelweis Egyetem

    Budapest 3054643, 1083
    Hungary

    Site Not Available

  • Clinexpert Kft. - Gyongyos

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Clinexpert Gyongyos Kft

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Clinexpert Gyongyos Kft

    Gyöngyös 3052040, 3200
    Hungary

    Site Not Available

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Sheba Medical Center - PPDS

    Ramat Gan, 5266202
    Israel

    Site Not Available

  • Sheba Medical Center - PPDS

    Ramat Gan 293788, 52621
    Israel

    Site Not Available

  • Sheba Medical Center - PPDS

    Ramat-Gan, 5262000
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv 293397, 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

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

    Meldola 3173635, Emilia-Romagna 3177401 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

    Site Not Available

  • Irccs Ospedale San Raffaele;Oncologia Medica

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardia 20089
    Italy

    Site Not Available

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan 3173435, Lombardy 3174618 20162
    Italy

    Site Not Available

  • Irccs Ospedale San Raffaele

    Milan 3173435, Lombardy 3174618 20132
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano (MI) 3168837, Lombardy 3174618 20089
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Toscana 56126
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa 3170647, Tuscany 3165361 56100
    Italy

    Site Not Available

  • Aga Khan University Hospital

    Nairobi, 00100
    Kenya

    Site Not Available

  • Aga Khan University Hospital

    Nairobi 184745, 00100
    Kenya

    Site Not Available

  • The Aga Khan University-Kenya.

    Nairobi 184745, 00100
    Kenya

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707
    Korea, Republic of

    Site Not Available

  • Asan Medical Center - PPDS

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • 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

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam 2759794, 1066 CX
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden 2751773, 2333 ZA
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht 2751283, 6229 HX
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht 2745912, 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

    Active - Recruiting

  • Auckland City Hospital

    Auckland 2193733,
    New Zealand

    Site Not Available

  • Auckland City Hospital, Cancer and Blood Research

    Auckland 2193733, 1023
    New Zealand

    Site Not Available

  • New Zealand Clinical Research - Christchurch

    Christchurch, 8011
    New Zealand

    Site Not Available

  • New Zealand Clinical Research - Christchurch

    Christchurch 2192362,
    New Zealand

    Site Not Available

  • Haukeland University Hospital

    Bergen, 5020
    Norway

    Site Not Available

  • Haukeland University Hospital; Hospital Pharmacy

    Bergen, 5053
    Norway

    Active - Recruiting

  • Haukeland University Hospital

    Bergen 3161732, 5020
    Norway

    Site Not Available

  • Oslo university hospital Radiumhospitalet

    Oslo, 0424
    Norway

    Site Not Available

  • Oslo university hospital Radiumhospitalet

    Oslo 3143244, 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

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

    Gdansk 3099434, 80-214
    Poland

    Site Not Available

  • Biokinetica, Przychodnia Jozefow

    Jozefow, 05-410
    Poland

    Site Not Available

  • Biokinetica, Przychodnia Jozefow

    Józefów 769981, 05-410
    Poland

    Site Not Available

  • 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

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna 7534652, 60-780
    Poland

    Site Not Available

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

    Kazan' 551487, Tatarstan Republic 484048 420029
    Russia

    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

  • Seoul National University Bundang Hospital

    Seongnam-si 1897000, 13605
    South Korea

    Site Not Available

  • Asan Medical Center - PPDS

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Samsung Medical Center - PPDS

    Seoul 1835848, 06351
    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 Universitari Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro-CIOCC

    Madrid, 28050
    Spain

    Completed

  • 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

  • Hospital Universitario HM Sanchinarro-CIOCC

    Madrid 3117735, 28050
    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

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Universitaetsspital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • Universitaetsspital Basel; Onkologie

    Basel, 4031
    Switzerland

    Site Not Available

  • Universitaetsspital Basel

    Basel 2661604, 4031
    Switzerland

    Site Not Available

  • Inselspital

    Bern, 3010
    Switzerland

    Site Not Available

  • Inselspital

    Bern 2661552, 3010
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève

    Geneva 2660646, 1211
    Switzerland

    Site Not Available

  • Hôpitaux Universitaires de Genève

    Genève, 1211
    Switzerland

    Site Not Available

  • Unversitätsspital Zürich

    Zurich 2657896, 8091
    Switzerland

    Site Not Available

  • Unversitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham 2655603, B15 2GW
    United Kingdom

    Site Not Available

  • Velindre Cancer Centre

    Cardiff, CF14 2TL
    United Kingdom

    Site Not Available

  • Velindre Cancer Centre

    Cardiff 2653822, CF14 2TL
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA
    United Kingdom

    Site Not Available

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

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • University College London Hospitals NHS Foundation Trust

    London 2643743, W1T 7HA
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester 2643123, 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

    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

  • City of Hope Comprehensive Cancer Center

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • UCSD Moores Cancer Center

    La Jolla 5363943, California 5332921 92093
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center UCI

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Univ of Calif, San Francisco

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Site Not Available

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Florida Cancer Specialists - Sarasota

    Sarasota 4172131, Florida 4155751 34232
    United States

    Site Not Available

  • Rush University Medical Center - PPDS

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • 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

  • University of Oklahoma

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • 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

  • Abramson Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • UPMC - Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

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