Clinical trial • Phase I • Oncology
RO7673396 for Advanced solid tumors with RAS mutations
Phase I trial of RO7673396 for Advanced solid tumors with RAS mutations. 275 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors with RAS mutations
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 20-06-2025
- First CTIS Authorization Date
- 22-09-2025
Trial design
Phase I trial across 13 sites in Belgium, Denmark, France and others.
- Biomarker Stratified
- True, RAS mutation(s)
- Target Sample Size
- 275
Recruitment
- Planned Sample Size
- 275
- Recruitment Window Months
- 41
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 70
Belgium
- Earliest CTIS Part Ii Submission Date
- 02-09-2025
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 164
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Universitair Ziekenhuis Antwerpen
- 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
- Institut Jules Bordet
- Principal Investigator Name
- Nuria Kotecki
- Principal Investigator Email
- nuria.kotecki@hubruxelles.be
- Contact Person Name
- Nuria Kotecki
- Contact Person Email
- nuria.kotecki@hubruxelles.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 10-09-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 152
- Number Of Sites
- 1
- Number Of Participants
- 10
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
- 25-08-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 189
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology
- Principal Investigator Name
- Nadim FARES
- Principal Investigator Email
- fares.nadim@iuct-oncopole.fr
- Contact Person Name
- Nadim FARES
- Contact Person Email
- fares.nadim@iuct-oncopole.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP
- 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
- 01-09-2025
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 169
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Asklepios Klinik Altona
- Principal Investigator Name
- Dirk Arnold
- Principal Investigator Email
- d.arnold@asklepios.com
- Contact Person Name
- Dirk Arnold
- Contact Person Email
- d.arnold@asklepios.com
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik I Studiensekretariat Internistische Onkologie
- Principal Investigator Name
- Gunnar Folprecht
- Principal Investigator Email
- oncostudy@ukdd.de
- Contact Person Name
- Gunnar Folprecht
- Contact Person Email
- oncostudy@ukdd.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Innere Klinik (Tumorforschung)
- Principal Investigator Name
- Martin Schuler
- Principal Investigator Email
- Martin.schuler@ukessen.de
- Contact Person Name
- Martin Schuler
- Contact Person Email
- Martin.schuler@ukessen.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 143
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sander Bins
- Principal Investigator Email
- s.bins@erasmusmc.nl
- Contact Person Name
- Sander Bins
- Contact Person Email
- s.bins@erasmusmc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medische Oncologische Discipline
- Principal Investigator Name
- Gerrina Ruiter
- Principal Investigator Email
- fase1secretariaat@nki.nl
- Contact Person Name
- Gerrina Ruiter
- Contact Person Email
- fase1secretariaat@nki.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 12-09-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 164
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical oncology
- Principal Investigator Name
- Rocío Garcia Carbonero
- Principal Investigator Email
- rgcarbonero@gmail.com
- Contact Person Name
- Rocío Garcia Carbonero
- Contact Person Email
- rgcarbonero@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical 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
- Clinica Universidad De Navarra
- Department Name
- Medical oncology
- Principal Investigator Name
- Mariano Ponz-Sarvisé
- Principal Investigator Email
- mponz@unav.es
- Contact Person Name
- Mariano Ponz-Sarvisé
- Contact Person Email
- mponz@unav.es
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- RO7673396
- Combination Treatment
- Yes
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