Clinical trial • Phase I • Oncology
TOS-358 for Colorectal cancer | Cervical cancer | Endometrial cancer | Gastric cancer | Urothelial cancer | Breast cancer | Head and neck cancer | Ovarian cancer | Non-small cell lung cancer
Phase I trial of TOS-358 for Colorectal cancer | Cervical cancer | Endometrial cancer | Gastric cancer | Urothelial cancer | Breast cancer | Head and neck…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colorectal cancer | Cervical cancer | Endometrial cancer | Gastric cancer | Urothelial cancer | Breast cancer | Head and neck cancer | Ovarian cancer | Non-small cell lung cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 03-10-2023
- First CTIS Authorization Date
- 10-01-2024
Trial design
Phase I trial across 10 sites in Spain.
- Target Sample Size
- 175
Eligibility
Recruits 175 No vulnerable populations selected ('isVulnerablePopulationSelected': false); trial population described as adults.
- Vulnerable Population
- No vulnerable populations selected ('isVulnerablePopulationSelected': false); trial population described as adults
Recruitment
- Planned Sample Size
- 175
- Recruitment Window Months
- 45
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 175
Spain
- Earliest CTIS Part Ii Submission Date
- 28-11-2023
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 875
- Number Of Sites
- 10
- Number Of Participants
- 175
Sites
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Contact Person Name
- Tatiana Hernández Guerrero
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Contact Person Name
- Jose Maria López-Picazo
- Contact Person Email
- jlpicazo@unav.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- vgambardella@incliva.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Irene Moreno
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Contact Person Name
- Aranzazu Fernandez
- Contact Person Email
- arancha.manzano@hotmail.com
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Oncology
- Contact Person Name
- Fabricio Racca
- Contact Person Email
- fracca@nextoncology.eu
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Clinica Universidad De Navarra (Madrid site)
- Department Name
- Oncology
- Contact Person Name
- Jose Maria López-Picazo
- Contact Person Email
- jlpicazo@unav.es
- Site Name
- Vall D Hebron Institute Of Oncology
- Department Name
- Oncology
- Contact Person Name
- Guzman Alonso Casal
- Contact Person Email
- galonso@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Bernard Doger de Speville Uribe
- Contact Person Email
- bernard.doger@startmadrid.com
Sponsor
Primary sponsor
- Full Name
- Totus Medicines Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- TOS-358
- First In Human
- Yes
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