Clinical trial • Phase I • Oncology
GDC-6036 for Advanced or metastatic solid tumour with KRAS G12C mutation
Phase I trial of GDC-6036 for Advanced or metastatic solid tumour with KRAS G12C mutation. 325 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced or metastatic solid tumour with KRAS G12C mutation
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-05-2024
- First CTIS Authorization Date
- 19-06-2024
Trial design
Phase I trial across 17 sites in Belgium, Norway, Hungary and others.
- Biomarker Stratified
- True, KRAS G12C (trial selects patients with KRAS G12C mutation)
- Target Sample Size
- 325
Recruitment
- Planned Sample Size
- 325
- Recruitment Window Months
- 61
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 156
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-06-2023
- Latest Decision Or Authorization Date
- 07-10-2025
- Processing Time Days
- 851
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- A.Z. Sint-Maarten
- Department Name
- Oncology
- Principal Investigator Name
- Marc Lambrechts
- Principal Investigator Email
- marc.lambrechts@emmaus.be
- Contact Person Name
- Marc Lambrechts
- Contact Person Email
- marc.lambrechts@emmaus.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Oncology
- Principal Investigator Name
- Pierre Frères
- Principal Investigator Email
- pfreres@chuliege.be
- Contact Person Name
- Pierre Frères
- Contact Person Email
- pfreres@chuliege.be
Norway
- Earliest CTIS Part Ii Submission Date
- 09-06-2023
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 847
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- The Department of Clinical Cancer Research
- Principal Investigator Name
- Tormod Kyrre Guren
- Principal Investigator Email
- uxtour@ous-hf.no
- Contact Person Name
- Tormod Kyrre Guren
- Contact Person Email
- uxtour@ous-hf.no
- Site Name
- Helse Bergen HF
- Department Name
- Departement of thoracic medicine, Section of lung cancer and infection
- Principal Investigator Name
- Øystein Fløtten
- Principal Investigator Email
- oystein.flotten@helse-bergen.no
- Contact Person Name
- Øystein Fløtten
- Contact Person Email
- oystein.flotten@helse-bergen.no
Hungary
- Earliest CTIS Part Ii Submission Date
- 09-06-2023
- Latest Decision Or Authorization Date
- 08-12-2024
- Processing Time Days
- 548
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Clinexpert Kft.
- Principal Investigator Name
- Istvan Lang
- Principal Investigator Email
- prof.lang.istvan@clinexpert.hu
- Contact Person Name
- Istvan Lang
- Contact Person Email
- prof.lang.istvan@clinexpert.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 09-06-2023
- Latest Decision Or Authorization Date
- 16-10-2025
- Processing Time Days
- 860
- Number Of Sites
- 1
- Number Of Participants
- 26
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- U.O. Oncologia Medica ed Ematologia
- Principal Investigator Name
- Armando Santoro
- Principal Investigator Email
- armando.santoro@humanitas.it
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@humanitas.it
Poland
- Earliest CTIS Part Ii Submission Date
- 09-06-2023
- Latest Decision Or Authorization Date
- 07-10-2025
- Processing Time Days
- 851
- Number Of Sites
- 1
- Number Of Participants
- 16
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Ośrodek Badań Klinicznych Wczesnych Faz
- Principal Investigator Name
- Rafał Dzadziuszko
- Principal Investigator Email
- rafald@gumed.edu.pl
- Contact Person Name
- Rafał Dzadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 09-06-2023
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 852
- Number Of Sites
- 6
- Number Of Participants
- 42
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Andrés Cervantes Ruiperez
- Principal Investigator Email
- andres.cervantes@uv.es
- Contact Person Name
- Andrés Cervantes Ruiperez
- Contact Person Email
- andres.cervantes@uv.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Luis Paz-Ares Rodríguez
- Principal Investigator Email
- lpazaresr@seom.org
- Contact Person Name
- Luis Paz-Ares Rodríguez
- Contact Person Email
- lpazaresr@seom.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Víctor Moreno García
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Víctor Moreno García
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Laura Medina Rodríguez
- Principal Investigator Email
- laura.medina@ibima.eu
- Contact Person Name
- Laura Medina Rodríguez
- Contact Person Email
- laura.medina@ibima.eu
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Elena Garralda Cabanas
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz (additional listed site entry)
- Department Name
- Oncology
- Principal Investigator Name
- Víctor Moreno García
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Víctor Moreno García
- Contact Person Email
- victor.moreno@startmadrid.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 09-06-2023
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 907
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Oncology
- Principal Investigator Name
- Loes Latten-Jansen
- Principal Investigator Email
- loes.jansen@mumc.nl
- Contact Person Name
- Loes Latten-Jansen
- Contact Person Email
- loes.jansen@mumc.nl
- Site Name
- Netherlands Cancer Institute
- Department Name
- Oncology
- Principal Investigator Name
- Marloes van Dongen
- Principal Investigator Email
- mg.v.dongen@nki.nl
- Contact Person Name
- Marloes van Dongen
- Contact Person Email
- mg.v.dongen@nki.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Oncology
- Principal Investigator Name
- Eelke Gort
- Principal Investigator Email
- e.h.gort-2@umcutrecht.nl
- Contact Person Name
- Eelke Gort
- Contact Person Email
- e.h.gort-2@umcutrecht.nl
Sponsor
Primary sponsor
- Full Name
- Genentech Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- GDC-6036
- Modality
- Small molecule
- Combination Treatment
- Yes
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