Clinical trial • Phase I • Oncology
BBO-8520 for Non-small cell lung cancer
Phase I trial of BBO-8520 for Non-small cell lung cancer. open-label. 224 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 12-01-2026
- First CTIS Authorization Date
- 12-03-2026
Trial design
open-label Phase I trial across 9 sites in Spain, Denmark.
- Open Label
- Yes
- Target Sample Size
- 224
Eligibility
Recruits 224 No vulnerable populations selected (isVulnerablePopulationSelected: false); no consent/assent handling or vulnerable-population-specific procedures described in the available record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false); no consent/assent handling or vulnerable-population-specific procedures described in the available record.
Recruitment
- Planned Sample Size
- 224
- Recruitment Window Months
- 23
- Consent Approach
- No informed consent or assent process details provided in the available record; who provides consent, age-specific documents, and languages are not described.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 45
Spain
- Earliest CTIS Part Ii Submission Date
- 26-02-2026
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 22
- Number Of Sites
- 8
- Number Of Participants
- 40
Sites
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Contact Person Name
- Antonio Calles
- Contact Person Email
- antonio.calles@live.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Contact Person Name
- Tatiana Hernandez
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- vgambardella@incliva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Maria Jové Casulleras
- Contact Person Email
- mjove@iconcologia.net
- Site Name
- Hospital Beata Maria Ana
- Department Name
- Oncology
- Contact Person Name
- Javier Cortés Castán
- Contact Person Email
- Javier.cortes@maj3.health.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 27-02-2026
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology, Phase I Unit
- Contact Person Name
- Martin Højgaard
- Contact Person Email
- martin.hoejgaard@regionh.dk
Sponsor
Primary sponsor
- Full Name
- Theras Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- BBO-8520
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