Clinical trial • Phase I • Oncology
NDI-219216 for Advanced solid tumors
Phase I trial of NDI-219216 for Advanced solid tumors. 80 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 20-06-2025
- First CTIS Authorization Date
- 15-09-2025
Trial design
Phase I trial across 7 sites in Spain, Portugal, Ireland and others.
- Target Sample Size
- 80
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 74
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 54
Spain
- Earliest CTIS Part Ii Submission Date
- 22-08-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 194
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Medical Oncology
- Contact Person Name
- Roberto Martin Huertas
- Contact Person Email
- roberto.martin@startresearch.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Medical Oncology
- Contact Person Name
- Jorge Bartolome Arcilla
- Contact Person Email
- jorge.bartolome@salud.madrid.org
Portugal
- Earliest CTIS Part Ii Submission Date
- 22-08-2025
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 193
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Start Research Portugal Unipessoal Lda.
- Department Name
- Medical Oncology
- Contact Person Name
- André Mansinho
- Contact Person Email
- andre.mansinho@startlisbon.com
Ireland
- Earliest CTIS Part Ii Submission Date
- 20-08-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 215
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Oncology
- Contact Person Name
- Austin Duffy
- Contact Person Email
- austin.duffy@startdublin.com
France
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 175
- Number Of Sites
- 3
- Number Of Participants
- 26
Sites
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Pole régionale de cancérologie Service d'Oncologie Médicale
- Contact Person Name
- David Tougeron
- Contact Person Email
- david.tougeron@chupoitiers.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d’oncologie médicale
- Contact Person Name
- Thierry André
- Contact Person Email
- thierry.andre@aphp.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- -
- Contact Person Name
- Cécile Vicier
- Contact Person Email
- vicierc@ipc.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Nimbus Wadjet Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- NDI-219216
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