Clinical trial • Phase I • Oncology|Gastroenterology
Bispecific antibody targeting CEACAM5 and CD3 for Colorectal cancer (locally advanced or metastatic)
Phase I trial of Bispecific antibody targeting CEACAM5 and CD3 for Colorectal cancer (locally advanced or metastatic). 12 participants.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology
- Trial Disease
- Colorectal cancer (locally advanced or metastatic)
- Trial Stage
- Phase I
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 01-02-2024
- First CTIS Authorization Date
- 06-03-2024
Trial design
Phase I trial across 2 sites in Spain.
- Target Sample Size
- 12
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 38
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 12
Spain
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 594
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Vall D'hebron Institut De Recerca
- Department Name
- Oncology
- Contact Person Name
- Iosune Baraibar Argota
- Contact Person Email
- ibaraibar@vhio.net
Sponsor
Primary sponsor
- Full Name
- NovImmune S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- NILK-2301
- Active Substance
- Bispecific antibody targeting CEACAM5 and CD3
- Modality
- Bispecific antibody
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