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New drug targets Hard-to-Treat cancers with KRAS mutation

NCT ID NCT04449874

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This early-phase study tests a new drug, GDC-6036, in people with advanced cancers (like lung or colorectal) that have a specific KRAS G12C mutation. The goal is to check safety and find the right dose, both when used alone and with other cancer drugs. About 498 participants will take part to see if the drug can shrink tumors or slow the disease.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 498 people

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

Started

Jul 2020

Expected to finish

Dec 2027

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.

Inclusion Criteria: * Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation. * 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 the final 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 after the final dose of study treatment as specified in the protocol. Exclusion Criteria: * Active brain metastases. * Malabsorption or other condition that interferes with enteral absorption. * Clinically significant cardiovascular dysfunction or liver disease.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

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

Advanced solid tumors Colorectal cancer Non-small cell lung cancer

Contacts and locations

Locations

  • AZ St Maarten Campus Leopoldstr

    Mechelen, 2800, Belgium

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Asan Medical Center - PPDS

    Seoul, 05505, South Korea

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, Lombardy, 20162, Italy

  • Auckland City Hospital

    Auckland, New Zealand

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023, New Zealand

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56100, Italy

  • Biokinetica, Przychodnia Jozefow

    Józefów, 05-410, Poland

  • CHU de Liège

    Liège, 4000, Belgium

  • Chao Family Comprehensive Cancer Center UCI

    Orange, California, 92868, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Clinexpert Gyongyos Kft

    Gyöngyös, 3200, Hungary

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, 34232, United States

  • 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

  • Haukeland University Hospital

    Bergen, 5020, Norway

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060, Brazil

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

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

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario HM Sanchinarro-CIOCC

    Madrid, 28050, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará, 90035-903, Brazil

  • Hôpitaux Universitaires de Genève

    Geneva, 1211, Switzerland

  • Inselspital

    Bern, 3010, Switzerland

  • Instituto Nacional de Câncer

    Rio de Janeiro, 20230-130, Brazil

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089, Italy

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

    Meldola, Emilia-Romagna, 47014, Italy

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • Linear Clinical Research Limited

    Nedlands, Western Australia, 6009, Australia

  • Maastricht University Medical Center

    Maastricht, 6229 HX, Netherlands

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • NIHR UCLH Clinical Research Facility

    London, W1T 7HA, United Kingdom

  • New Zealand Clinical Research - Christchurch

    Christchurch, New Zealand

  • Oslo university hospital Radiumhospitalet

    Oslo, 0424, Norway

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth Hospital

    Birmingham, B15 2GW, United Kingdom

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Samsung Medical Center - PPDS

    Seoul, 06351, South Korea

  • Santa Casa de Misericordia de Belo Horizonte - PPDS

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Slade Health Inward goods

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

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Aga Khan University-Kenya.

    Nairobi, 00100, Kenya

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • UCSD Moores Cancer Center

    La Jolla, California, 92093, United States

  • UPMC - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • Universidade de Caxias do Sul

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

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

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

    Gdansk, 80-214, Poland

  • Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

  • Yale Cancer Center

    New Haven, Connecticut, 06511, United States

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Other studies related to the condition(s) this trial covers.