Clinical trial • Phase I • Oncology
XXX for Malignant solid tumour expressing CEACAM5 (CEA)
Phase I trial of XXX for Malignant solid tumour expressing CEACAM5 (CEA).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Malignant solid tumour expressing CEACAM5 (CEA)
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 18-03-2024
- First CTIS Authorization Date
- 11-06-2024
Trial design
Randomised, combination of xxx with xxx vs standard of care (no doses or schedule specified)-controlled Phase I trial across 4 sites in Spain.
- Randomised
- Yes
- Comparator
- Combination of XXX with XXX vs standard of care (no doses or schedule specified)
- Target Sample Size
- 50
Eligibility
Recruits 50 No vulnerable populations selected (isVulnerablePopulationSelected = false). Consent/assent handling not provided in the record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected = false). Consent/assent handling not provided in the record.
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 54
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 50
Spain
- Earliest CTIS Part Ii Submission Date
- 09-05-2024
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 707
- Number Of Sites
- 4
- Number Of Participants
- 50
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Jon Zugazagoitia
- Principal Investigator Email
- ionzuga@gmail.com
- Contact Person Name
- Jon Zugazagoitia
- Contact Person Email
- ionzuga@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Mariano Ponz
- Principal Investigator Email
- mponz@unav.es
- Contact Person Name
- Mariano Ponz
- Contact Person Email
- mponz@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Josep Tabernero
- Principal Investigator Email
- jtabernero@vhio.net
- Contact Person Name
- Josep Tabernero
- Contact Person Email
- jtabernero@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Víctor Moreno
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Víctor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
Sponsor
Primary sponsor
- Full Name
- NovImmune SA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- XXX
- Investigational Product Name
- anti-PD-1 antibody
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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