Sign in

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.
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

Full criteria on ClinicalTrials.gov

Sites (63)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peter MacCallum Cancer Center
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Alfred Health
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Slade Health Inward goods
Coordinator of this site? Confirm its status
Mount Kuring-GaiAustraliaUnknown status
Linear Clinical Research Limited
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
UZ Antwerpen
Coordinator of this site? Confirm its status
EdegemBelgiumUnknown status
CHU de Liège
Coordinator of this site? Confirm its status
LiègeBelgiumUnknown status
AZ St Maarten Campus Leopoldstr
Coordinator of this site? Confirm its status
MechelenBelgiumUnknown status
Santa Casa de Misericordia de Belo Horizonte - PPDS
Coordinator of this site? Confirm its status
Belo HorizonteBrazilUnknown status
Universidade de Caxias do Sul
Coordinator of this site? Confirm its status
Caxias do SulBrazilUnknown status
Hospital Erasto Gaertner
Coordinator of this site? Confirm its status
CuritibaBrazilUnknown status
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Hospital de Clinicas de Porto Alegre HCPA PPDS
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Instituto Nacional de Câncer
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown 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 PretoBrazilUnknown status
Jewish General Hospital
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Ottawa Hospital
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Inselspital
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Hôpitaux universitaires de Genève
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Universitario HM Sanchinarro CIOCC
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hospital Clinico Universitario Virgen de La Victoria
Coordinator of this site? Confirm its status
MálagaSpainUnknown status
Hospital Universitario Virgen del Rocio
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Queen Elizabeth Hospital
Coordinator of this site? Confirm its status
BirminghamUnited KingdomUnknown status
Velindre Cancer Centre
Coordinator of this site? Confirm its status
CardiffUnited KingdomUnknown status
NIHR UCLH Clinical Research Facility
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Clinexpert Gyöngyös Kft.
Coordinator of this site? Confirm its status
GyöngyösHungaryUnknown status
Rambam Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Tel-Aviv Sourasky Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Coordinator of this site? Confirm its status
MeldolaItalyUnknown status
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Azienda Ospedaliero Universitaria Pisana
Coordinator of this site? Confirm its status
PisaItalyUnknown status
Istituto Clinico Humanitas
Coordinator of this site? Confirm its status
Rozzano (MI)ItalyUnknown status
The Aga Khan University-Kenya.
Coordinator of this site? Confirm its status
NairobiKenyaUnknown status
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaUnknown status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Asan Medical Center - PPDS
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Samsung Medical Center - PPDS
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Leids Universitair Medisch Centrum
Coordinator of this site? Confirm its status
LeidenNetherlandsUnknown status
Maastricht University Medical Center
Coordinator of this site? Confirm its status
MaastrichtNetherlandsUnknown status
Universitair Medisch Centrum Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status
Haukeland University Hospital
Coordinator of this site? Confirm its status
BergenNorwayUnknown status
Oslo University Hospital - Radiumhospitalet
Coordinator of this site? Confirm its status
OsloNorwayUnknown status
Auckland City Hospital
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status
Auckland City Hospital, Cancer and Blood Research
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status
New Zealand Clinical Research - Christchurch
Coordinator of this site? Confirm its status
ChristchurchNew ZealandUnknown status
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Coordinator of this site? Confirm its status
GdanskPolandUnknown status
Biokinetica, Przychodnia Jozefow
Coordinator of this site? Confirm its status
JózefówPolandUnknown status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
UCSD Moores Cancer Center
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Yale Cancer Center
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of Oklahoma
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Chao Family Comprehensive Cancer Center UCI
Coordinator of this site? Confirm its status
OrangeUnited StatesUnknown status
UPMC Hillman Cancer Center
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
Florida Cancer Specialists - Sarasota
Coordinator of this site? Confirm its status
SarasotaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.