Clinical trial • Phase I • Oncology
Clinical trial in KRAS-altered advanced or metastatic solid tumors | Colorectal cancer | Pancreatic ductal adenocarcinoma | Non-small cell lung cancer
Phase I trial for KRAS-altered advanced or metastatic solid tumors | Colorectal cancer | Pancreatic ductal adenocarcinoma | Non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- KRAS-altered advanced or metastatic solid tumors | Colorectal cancer | Pancreatic ductal adenocarcinoma | Non-small cell lung cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 08-07-2025
- First CTIS Authorization Date
- 28-10-2025
Trial design
Phase I trial across 14 sites in Denmark, France, Germany and others.
- Biomarker Stratified
- True, biomarker=KRAS alteration; strata not specified
- Target Sample Size
- 294
Recruitment
- Planned Sample Size
- 294
- Recruitment Window Months
- 60
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 135
Denmark
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 28-10-2025
- Processing Time Days
- 25
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Principal Investigator Name
- Kristoffer Staal Rohrberg
- Principal Investigator Email
- Kristoffer.Staal.Rohrberg@regionh.dk
- Contact Person Name
- Kristoffer Staal Rohrberg
- Contact Person Email
- Kristoffer.Staal.Rohrberg@regionh.dk
France
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 54
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Philippe Cassier
- Principal Investigator Email
- philippe.cassier@lyon.unicancer.fr
- Contact Person Name
- Philippe Cassier
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical oncology department
- Principal Investigator Name
- Loic Lebellec
- Principal Investigator Email
- l-lebellec@o-lambret.fr
- Contact Person Name
- Loic Lebellec
- Contact Person Email
- l-lebellec@o-lambret.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP Drug Development Department
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 07-10-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 14
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Innere Klinik (Tumorforschung)
- Principal Investigator Name
- Isabel Virchow
- Principal Investigator Email
- isabel.virchow@uk-essen.de
- Contact Person Name
- Isabel Virchow
- Contact Person Email
- isabel.virchow@uk-essen.de
Italy
- Earliest CTIS Part Ii Submission Date
- 01-10-2025
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 23
Sites
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Ematologia e Oncologia
- Principal Investigator Name
- Alessio Amatu
- Principal Investigator Email
- alessio.amatu@ospedaleniguarda.it
- Contact Person Name
- Alessio Amatu
- Contact Person Email
- alessio.amatu@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Oncologia
- Principal Investigator Name
- Chiara Cremolini
- Principal Investigator Email
- chiaracremolini@gmail.com
- Contact Person Name
- Chiara Cremolini
- Contact Person Email
- chiaracremolini@gmail.com
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Oncologia
- Principal Investigator Name
- Michele Milella
- Principal Investigator Email
- michele.milella@univr.it
- Contact Person Name
- Michele Milella
- Contact Person Email
- michele.milella@univr.it
Spain
- Earliest CTIS Part Ii Submission Date
- 23-09-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 38
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Rocio Rocio Garcia Carbonero
- Principal Investigator Email
- rgcarbonero@gmail.com
- Contact Person Name
- Rocio Rocio Garcia Carbonero
- Contact Person Email
- rgcarbonero@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Victor Moreno Garcia
- Principal Investigator Email
- Victor.Moreno@startmadrid.com
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- Victor.Moreno@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Elena Garralda Cabanas
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Netherlands
- Earliest CTIS Part Ii Submission Date
- 26-09-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 33
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Medische Oncologie
- Principal Investigator Name
- Jeanine Roodhart
- Principal Investigator Email
- j.roodhart@umcutrecht.nl
- Contact Person Name
- Jeanine Roodhart
- Contact Person Email
- j.roodhart@umcutrecht.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-09-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 125
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Oncology
- Principal Investigator Name
- Sylvie Rottey
- Principal Investigator Email
- Sylvie.rottey@ugent.be
- Contact Person Name
- Sylvie Rottey
- Contact Person Email
- Sylvie.rottey@ugent.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- 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
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)