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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
Sponsor: Genentech, Inc.
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.
Official title: A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
498
Start Date
2020-07-29
Completion Date
2027-12-31
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
GDC-6036
The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation).
Atezolizumab
A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
Cetuximab
Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m\^2) IV infusion followed by 250 mg/m\^2 IV infusion weekly in 21 day cycles.
Bevacizumab
A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
Erlotinib
150 mg of erlotinib will be administered PO QD in 21 day cycles.
GDC-1971
The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
Inavolisib
The starting dose of inavolisib will be determined from its single-agent dose escalation.
Locations (63)
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, United States
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Slade Health Inward goods
Mount Kuring-Gai, New South Wales, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
UZ Antwerpen
Edegem, Belgium
CHU de Liège
Liège, Belgium
AZ St Maarten Campus Leopoldstr
Mechelen, Belgium
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
Pôrto Alegre, Pará, Brazil
Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Nacional de Câncer
Rio de Janeiro, Brazil
Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Clinexpert Gyongyos Kft
Gyöngyös, Hungary
Rambam Medical Center
Haifa, Israel
Sheba Medical Center - PPDS
Ramat Gan, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, Emilia-Romagna, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
The Aga Khan University-Kenya.
Nairobi, Kenya
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Auckland City Hospital, Cancer and Blood Research
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
New Zealand Clinical Research - Christchurch
Christchurch, New Zealand
Haukeland University Hospital
Bergen, Norway
Oslo university hospital Radiumhospitalet
Oslo, Norway
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Gdansk, Poland
Biokinetica, Przychodnia Jozefow
Józefów, Poland
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center - PPDS
Seoul, South Korea
Samsung Medical Center - PPDS
Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Inselspital
Bern, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Queen Elizabeth Hospital
Birmingham, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom