NCT04449874Active, not recruitingPhase 1
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
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
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 498 (estimated)
- First submitted
- 24 Jun 2020
- Start date
- 29 Jul 2020
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Genentech, Inc.
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT04449874
- EU CT number
- 2023-506311-18-00
- EudraCT number
- 2020-000084-22
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 498
- From 29 Jul 2020 to the primary completion date, 31 Dec 2027
- 63 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Malabsorption or other condition that interferes with enteral absorption.
- Clinically significant cardiovascular dysfunction or liver disease.
Other
- Active brain metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (63)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Center Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Slade Health Inward goods Coordinator of this site? Confirm its status | Mount Kuring-Gai | Australia | Unknown status |
| Linear Clinical Research Limited Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| AZ St Maarten Campus Leopoldstr Coordinator of this site? Confirm its status | Mechelen | Belgium | Unknown status |
| Santa Casa de Misericordia de Belo Horizonte - PPDS Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Universidade de Caxias do Sul Coordinator of this site? Confirm its status | Caxias do Sul | Brazil | Unknown status |
| Hospital Erasto Gaertner Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre HCPA PPDS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto Nacional de Câncer Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hôpitaux universitaires de Genève Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| START Madrid-FJD, Hospital Fundacion Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario HM Sanchinarro CIOCC Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clinico Universitario Virgen de La Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Velindre Cancer Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| NIHR UCLH Clinical Research Facility Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Clinexpert Gyöngyös Kft. Coordinator of this site? Confirm its status | Gyöngyös | Hungary | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano (MI) | Italy | Unknown status |
| The Aga Khan University-Kenya. Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Leids Universitair Medisch Centrum Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Oslo University Hospital - Radiumhospitalet Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Auckland City Hospital, Cancer and Blood Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| New Zealand Clinical Research - Christchurch Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Biokinetica, Przychodnia Jozefow Coordinator of this site? Confirm its status | Józefów | Poland | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| UCSD Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Chao Family Comprehensive Cancer Center UCI Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Florida Cancer Specialists - Sarasota Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.