Clinical trial • Phase I • Oncology
KISIMA-02 for Pancreatic ductal adenocarcinoma (KRAS G12D/G12V)
Phase I trial of KISIMA-02 for Pancreatic ductal adenocarcinoma (KRAS G12D/G12V). 57 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Pancreatic ductal adenocarcinoma (KRAS G12D/G12V)
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 06-10-2023
- First CTIS Authorization Date
- 04-04-2024
Trial design
Phase I trial across 9 sites in France, Spain, Germany.
- Biomarker Stratified
- True - KRAS G12D/G12V
- Target Sample Size
- 57
Eligibility
Recruits 57 Vulnerable population selected (no details on consent or assent handling provided in the available documents).
- Vulnerable Population
- Vulnerable population selected (no details on consent or assent handling provided in the available documents)
Recruitment
- Planned Sample Size
- 57
- Recruitment Window Months
- 38
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 37
France
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 858
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Institut Curie
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Cindy Neuzillet
- Principal Investigator Email
- cindy.neuzillet@curie.fr
- Contact Person Name
- Cindy Neuzillet
- Contact Person Email
- cindy.neuzillet@curie.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
Spain
- Earliest CTIS Part Ii Submission Date
- 24-10-2023
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 913
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Irene Moreno Candilejo
- Principal Investigator Email
- irene.moreno@startmadrid.com
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Andres Munoz
- Principal Investigator Email
- andresmunmar@hotmail.com
- Contact Person Name
- Andres Munoz
- Contact Person Email
- andresmunmar@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Jaume Capdevila Castillon
- Principal Investigator Email
- jcapdevila@vhio.net
- Contact Person Name
- Jaume Capdevila Castillon
- Contact Person Email
- jcapdevila@vhio.net
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Oncology
- Principal Investigator Name
- Maria Teresa Cano
- Principal Investigator Email
- maytecano79@hotmail.com
- Contact Person Name
- Maria Teresa Cano
- Contact Person Email
- maytecano79@hotmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Victor Moreno
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
Germany
- Earliest CTIS Part Ii Submission Date
- 17-01-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 832
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Medical Oncology
- Principal Investigator Name
- Guy Ungerechts
- Principal Investigator Email
- guy.ungerechts@nct-heidelberg.de
- Contact Person Name
- Guy Ungerechts
- Contact Person Email
- guy.ungerechts@nct-heidelberg.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Medical Oncology
- Principal Investigator Name
- Dirk Arnold
- Principal Investigator Email
- d.arnold@asklepios.com
- Contact Person Name
- Dirk Arnold
- Contact Person Email
- d.arnold@asklepios.com
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- KISIMA-02
- Modality
- Vaccine
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