Clinical trial • Phase I • Oncology
BI 1703880 for Advanced solid tumours
Phase I trial of BI 1703880 for Advanced solid tumours. adaptive. 74 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumours
- Trial Stage
- Phase I
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 22-05-2024
- First CTIS Authorization Date
- 05-07-2024
Trial design
adaptive Phase I trial across 4 sites in Spain.
- Adaptive
- True, dose escalation design overseen by a dose escalation committee; temporary halt criteria referenced in protocol Section 3.1.1.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 74
Recruitment
- Planned Sample Size
- 74
- Recruitment Window Months
- 47
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 74
Spain
- Earliest CTIS Part Ii Submission Date
- 07-06-2024
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 602
- Number Of Sites
- 4
- Number Of Participants
- 26
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- START Madrid-HM CIOCC Early Phase Program
- Contact Person Name
- Irene Moreno
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Servicio de Oncología
- Contact Person Name
- David Lorente Estellés
- Contact Person Email
- dlorente@fivo.org
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology Department
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- valen.gambardella@gmail.com
- Site Name
- Vall D Hebron Institute Of Oncology
- Department Name
- Oncology Department
- Contact Person Name
- Guzman Alonso
- Contact Person Email
- galonso@vhio.net
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 1703880
- Active Substance
- BI 1703880
- Modality
- Small molecule
- Investigational Product Name
- ezabenlimab
- Active Substance
- ezabenlimab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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