Clinical trial • Phase I • Oncology
Clinical trial in Cancer (eligible for second-line treatment)
Phase I trial for Cancer (eligible for second-line treatment). open-label, adaptive. 60 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cancer (eligible for second-line treatment)
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 28-03-2025
- First CTIS Authorization Date
- 30-06-2025
Trial design
open-label, adaptive Phase I trial across 4 sites in Spain.
- Open Label
- Yes
- Adaptive
- True - Dose escalation with an expansion cohort; no detailed escalation rules or interim analysis/stopping rules provided in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 60
Eligibility
Recruits 60 Vulnerable population selected; no details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 60
Spain
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 30-06-2025
- Processing Time Days
- 34
- Number Of Sites
- 4
- Number Of Participants
- 60
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical Oncology
- Contact Person Name
- Emiliano Calvo Aller
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Contact Person Name
- Ignacio Javier Melero Bermejo
- Contact Person Email
- imelero@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Contact Person Name
- Víctor Moreno García
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Medical Oncology
- Contact Person Name
- Ignacio Javier Melero Bermejo
- Contact Person Email
- imelero@unav.es
Sponsor
Primary sponsor
- Full Name
- NovImmune S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Combination Treatment
- Yes
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