Clinical trial • Phase I • Oncology|Respiratory
BL-B01D1 for Non-small cell lung cancer|Other solid tumors
Phase I trial of BL-B01D1 for Non-small cell lung cancer|Other solid tumors. 376 participants.
Overview
- Trial Therapeutic Area
- Oncology|Respiratory
- Trial Disease
- Non-small cell lung cancer|Other solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 26-01-2024
- First CTIS Authorization Date
- 20-05-2024
Trial design
Phase I trial across 14 sites in France, Spain, Italy.
- Target Sample Size
- 376
Eligibility
Recruits 376 No vulnerable population selected; no consent or assent details provided..
- Vulnerable Population
- No vulnerable population selected; no consent or assent details provided.
Recruitment
- Planned Sample Size
- 376
- Recruitment Window Months
- 43
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 95
France
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 748
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP
- Contact Person Name
- Anas Gazzah
- Contact Person Email
- anas.gazzah@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Johanna WASSERMANN
- Contact Person Email
- johanna.wassermann@aphp.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Contact Person Name
- Sandrine HIRET
- Contact Person Email
- sandrine.hiret@ico.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical Oncology
- Contact Person Name
- Aurelie SWALDUZ
- Contact Person Email
- aurelie.swalduz@lyon.unicancer.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 598
- Number Of Sites
- 8
- Number Of Participants
- 35
Sites
- Site Name
- Hospital Beata Maria Ana
- Department Name
- Oncology
- Contact Person Name
- Javier Cortes Castan
- Contact Person Email
- Javier.cortes@maj3.health
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Contact Person Name
- Margarita MajemTarruella
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Ester Garcia Lorenzo
- Contact Person Email
- Ester.Garcia@startmadrid.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Ramon Yarza Barrio
- Contact Person Email
- ramon.yarza@startmadrid.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Santiago Ponce Aix
- Contact Person Email
- sponce@hotmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Contact Person Name
- David Vicente Baz
- Contact Person Email
- dvicentebaz@yahoo.es
- Site Name
- Fundacion Rioja Salud
- Department Name
- Oncology
- Contact Person Name
- Maria De Miguel
- Contact Person Email
- maria.demiguel@startrioja.com
Italy
- Earliest CTIS Part Ii Submission Date
- 18-04-2024
- Latest Decision Or Authorization Date
- 11-12-2025
- Processing Time Days
- 602
- Number Of Sites
- 2
- Number Of Participants
- 39
Sites
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
- Department Name
- Department of Oncology, Istituto di Candiolo Fondazione del Piemonte per l’oncologia IRCCS
- Contact Person Name
- Vanesa Gregorc
- Contact Person Email
- vanesa.gregorc@ircc.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Medical Oncology Unit, Humanitas Cancer Center, IRCCS Istituto Clinico Humanitas
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@cancercenter.humanitas.it
Sponsor
Primary sponsor
- Full Name
- Systimmune Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- BL-B01D1
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