Clinical trial • Phase I • Oncology
BBO-10203 for Solid Tumors
Phase I trial of BBO-10203 for Solid Tumors. adaptive. 317 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid Tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 11-12-2024
- First CTIS Authorization Date
- 04-04-2025
Trial design
adaptive Phase I trial across 25 sites in Spain, France, Italy.
- Adaptive
- True - dose escalation and dose expansion design (title indicates dose escalation/expansion); no further adaptive details provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 317
Recruitment
- Planned Sample Size
- 317
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 91
Spain
- Earliest CTIS Part Ii Submission Date
- 27-03-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 270
- Number Of Sites
- 11
- Number Of Participants
- 46
Sites
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- Tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Contact Person Name
- Oscar Jose Juan Vidal
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Rafael Villanueva Vazquez
- Contact Person Email
- ravillanueva@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Santiago Ponce Aix
- Contact Person Email
- santiago.ponce@oncosur.org
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology
- Contact Person Name
- Angel Guerrero Zotano
- Contact Person Email
- AGUERRERO@FIVO.ORG
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Oncology
- Contact Person Name
- Serafin Morales Murillo
- Contact Person Email
- serafinmorales01@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Cristina Saura Manich
- Contact Person Email
- csaura@vhio.net
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Oncology
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@nextoncology.eu
- Site Name
- Hospital Beata Maria Ana
- Department Name
- Oncology
- Contact Person Name
- Javier Cortes Castan
- Contact Person Email
- javier.cortes@maj3.health.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- victor.moreno@startmadrid.com
France
- Earliest CTIS Part Ii Submission Date
- 26-03-2025
- Latest Decision Or Authorization Date
- 19-12-2025
- Processing Time Days
- 268
- Number Of Sites
- 6
- Number Of Participants
- 29
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Department of Therapeutic Innovation and Early Trials
- Contact Person Name
- Christophe Massard
- Contact Person Email
- christophe.massard@gustaveroussy.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Contact Person Name
- Mario Campone
- Contact Person Email
- mario.campone@ico.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Philippe Cassier
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Medical Oncology
- Contact Person Name
- Diego Tosi
- Contact Person Email
- diego.tosi@icm.unicancer.fr
- Site Name
- Institut Curie
- Department Name
- Medical Oncology
- Contact Person Name
- Diana Bello-Roufai
- Contact Person Email
- diana.belloroufai@curie.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Maxime Brunet
- Contact Person Email
- m.brunet@bordeaux.unicancer.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 100
- Number Of Sites
- 8
- Number Of Participants
- 16
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncology Medicine Unit
- Contact Person Name
- Gianluca Del Conte
- Contact Person Email
- delconte.gianluca@hsr.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- Medical Oncology and Cancer Prevention
- Contact Person Name
- Fabio Puglisi
- Contact Person Email
- fabio.puglisi@cro.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Phase 1 Unit
- Contact Person Name
- Matteo Duca
- Contact Person Email
- Matteo.Duca@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Phase 1
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Clinical Oncology Departmental Unit
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- lorenzo.antonuzzo@gmail.com
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Dpt Internal Medicine- SOD Clinic Oncology
- Contact Person Name
- Rossana Berardi
- Contact Person Email
- rossana.berardi@ospedaliriuniti.marche.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Oncology division
- Contact Person Name
- Michelino De Laurentiis
- Contact Person Email
- m.delaurentiis@istitutotumori.na.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Development of New Drugs for Innovative Therapies
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
Sponsor
Primary sponsor
- Full Name
- Theras Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- BBO-10203
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