Clinical trial • Phase I • Oncology
sotorasib for Advanced solid tumours with KRAS G12C mutation
Phase I trial of sotorasib for Advanced solid tumours with KRAS G12C mutation. 39 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumours with KRAS G12C mutation
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 31-07-2024
- First CTIS Authorization Date
- 27-10-2024
Trial design
Phase I trial across 6 sites in Denmark, Italy, Spain.
- Biomarker Stratified
- True, biomarker: KRAS G12C mutation (participants selected based on presence)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 39
Eligibility
Recruits 39 Vulnerable population selected; no further details on consent or assent handling provided in the available data..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling provided in the available data.
Recruitment
- Planned Sample Size
- 39
- Recruitment Window Months
- 39
- Consent Approach
- Informed consent process not provided in the available data; no details on assent, age-specific documents or languages available.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 53
Denmark
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 476
- Number Of Sites
- 1
- Number Of Participants
- 19
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of oncology
- Principal Investigator Name
- Kristoffer Rohrberg
- Principal Investigator Email
- kfe-sekretariat.rigshospitalet@regionh.dk
- Contact Person Name
- Kristoffer Rohrberg
- Contact Person Email
- kfe-sekretariat.rigshospitalet@regionh.dk
Italy
- Earliest CTIS Part Ii Submission Date
- 04-10-2024
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 493
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncologia Medica ed Ematologia
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simonelli@cancercenter.humanitas.it
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@cancercenter.humanitas.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Gennaro Daniele
- Principal Investigator Email
- gennaro.daniele@policlinicogemelli.it
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
Spain
- Earliest CTIS Part Ii Submission Date
- 10-10-2024
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 571
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncologist
- Principal Investigator Name
- María Jové Casulleras
- Principal Investigator Email
- mjove@iconcologia.net
- Contact Person Name
- María Jové Casulleras
- Contact Person Email
- mjove@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncologist
- 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
- Institut Catala D'oncologia
- Department Name
- Medical Oncologist
- Principal Investigator Name
- José Carlos Ruffinelli Rodríguez
- Principal Investigator Email
- jruffinelli@iconcologia.net
- Contact Person Name
- José Carlos Ruffinelli Rodríguez
- Contact Person Email
- jruffinelli@iconcologia.net
Sponsor
Primary sponsor
- Full Name
- Bayer AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BAY 3498264
- Investigational Product Name
- sotorasib
- Active Substance
- sotorasib
- Combination Treatment
- Yes
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