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Search / Trial NCT04449874

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

Launched by GENENTECH, INC. · Jun 24, 2020

Trial Information

Current as of September 09, 2025

Recruiting

Keywords

Kras G12 C Non Small Cell Lung Cancer Colorectal Cancer Gdc 6036 Metastatic Solid Tumor Atezolizumab Bevacizumab Cetuximab Erlotinib Inavolisib Gdc 1971 Shp2

ClinConnect Summary

This clinical trial is investigating a new treatment called GDC-6036 for patients with advanced or metastatic solid tumors that have a specific mutation known as KRAS G12C. The trial aims to understand how safe this treatment is, how the body processes it, and whether it shows any signs of effectiveness. Patients eligible to join the study must have a confirmed diagnosis of a solid tumor with the KRAS G12C mutation and meet specific health requirements, such as avoiding certain conditions that could complicate treatment.

Participants in the trial can expect to receive GDC-6036 either on its own or in combination with other treatments, depending on the study design. The research team will closely monitor their health and response to the medication throughout the study. It's important for potential participants to know that women of childbearing age need to take precautions to avoid pregnancy, and men must also take measures to prevent fathering a child during the trial. This study is currently looking for volunteers, so if you or someone you know may qualify, it could be an opportunity to contribute to important cancer research.

Gender

ALL

Eligibility criteria

  • 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.

About Genentech, Inc.

Genentech, Inc. is a leading biotechnology company and a member of the Roche Group, dedicated to transforming the lives of patients with serious medical conditions through innovative therapies. Established in 1976, Genentech is recognized for its pioneering research in biologics and for developing groundbreaking treatments in areas such as oncology, immunology, and neuroscience. With a commitment to scientific excellence and patient-centered care, the company leverages cutting-edge technology and collaborative partnerships to advance drug discovery and development. Genentech's robust pipeline and focus on personalized medicine underscore its mission to address unmet medical needs and improve health outcomes globally.

Locations

New York, New York, United States

Duarte, California, United States

New York, New York, United States

Valencia, , Spain

Boston, Massachusetts, United States

Oklahoma City, Oklahoma, United States

Seoul, , Korea, Republic Of

Birmingham, , United Kingdom

Basel, , Switzerland

Montreal, Quebec, Canada

Curitiba, , Brazil

Malaga, , Spain

New Haven, Connecticut, United States

Ottawa, Ontario, Canada

Auckland, , New Zealand

Pittsburgh, Pennsylvania, United States

Edegem, , Belgium

Auckland, , New Zealand

La Jolla, California, United States

Sevilla, , Spain

Philadelphia, Pennsylvania, United States

Barcelona, , Spain

Bern, , Switzerland

Manchester, , United Kingdom

Seoul, , Korea, Republic Of

Sao Paulo, Sp, Brazil

Barretos, Sp, Brazil

Madrid, , Spain

Utrecht, , Netherlands

Cardiff, , United Kingdom

Gdansk, , Poland

Budapest, , Hungary

San Francisco, California, United States

North Melbourne, Victoria, Australia

Toronto, Ontario, Canada

Liège, , Belgium

Budapest, , Hungary

Maastricht, , Netherlands

Darlinghurst, New South Wales, Australia

Basel, , Switzerland

Leiden, , Netherlands

Curitiba, Paraná, Brazil

Genève, , Switzerland

Birmingham, , United Kingdom

Seongnam Si, Gyeonggi Do, Korea, Republic Of

Milano, Lombardia, Italy

Dresden, , Germany

Milano, , Italy

Philadelphia, Pennsylvania, United States

Sarasota, Florida, United States

London, , United Kingdom

Oklahoma City, Oklahoma, United States

Melbourne, Victoria, Australia

Bergen, , Norway

Haifa, , Israel

Nedlands, Western Australia, Australia

Tel Aviv, , Israel

Curitiba, Pr, Brazil

Pisa, Toscana, Italy

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Pisa, Toscana, Italy

New Haven, Connecticut, United States

Rozzano (Mi), Lombardia, Italy

Amsterdam, , Netherlands

Melbourne, Victoria, Australia

Porto Alegre, Rio Grande Do Sul, Brazil

Madrid, , Spain

Orange, California, United States

Madrid, , Spain

Kazan, Tatarstan, Russian Federation

Milano, Lombardia, Italy

Mechelen, , Belgium

Poznań, , Poland

London, , United Kingdom

Auckland, , New Zealand

Herstal, , Belgium

Ramat Gan, , Israel

Meldola, Emilia Romagna, Italy

Nairobi, , Kenya

Montreal, Quebec, Canada

Ramat Gan, , Israel

Christchurch, , New Zealand

Oslo, , Norway

Jozefow, , Poland

Zürich, , Switzerland

Nairobi, , Kenya

Sao Jose Do Rio Preto, Sp, Brazil

Porto Alegre, Pa, Brazil

Christchurch, , New Zealand

Bergen, , Norway

Belo Horizonte, Mg, Brazil

Porto Alegre, Rs, Brazil

Budapest, , Hungary

New York, New York, United States

Caxias Do Sul, Rs, Brazil

Rio De Janeiro, Rj, Brazil

Pozna?, , Poland

Gyongyos, , Hungary

Mount Kuring Gai, New South Wales, Australia

Porto Alegre, Pa, Brazil

Belo Horizonte, Mg, Brazil

Ramat Gan, , Israel

Budapest, , Hungary

Sao Paulo, , Brazil

Gyöngyös, , Hungary

Sao Paulo, São Paulo, Brazil

Barretos, São Paulo, Brazil

Sao Jose Do Rio Preto, São Paulo, Brazil

San Francisco, California, United States

Belo Horizonte, Minas Gerais, Brazil

Porto Alegre, Pará, Brazil

Caxias Do Sul, Rio Grande Do Sul, Brazil

Rio De Janeiro, , Brazil

Gdansk, , Poland

Barretos, , Brazil

Porto Alegre, , Brazil

Sao Jose Do Rio Preto, , Brazil

Patients applied

0 patients applied

Trial Officials

Clinical Trials

Study Director

Genentech, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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