Clinical trial • Phase I • Oncology
TSR-022 for Advanced solid tumors
Phase I trial of TSR-022 for Advanced solid tumors. None/Not specified-controlled. 1221 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 18-12-2023
- First CTIS Authorization Date
- 30-01-2024
Trial design
None/Not specified-controlled Phase I trial across 21 sites in Spain.
- Comparator
- None/Not specified
- Target Sample Size
- 1221
Eligibility
Recruits 1221 Vulnerable population selected; no details on consent or assent handling provided..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided.
Recruitment
- Planned Sample Size
- 1221
- Recruitment Window Months
- 140
- Consent Approach
- Not specified in available documents; no details on informed consent, assent, age-specific documents, or languages.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 1221
Spain
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 19-12-2025
- Processing Time Days
- 697
- Number Of Sites
- 21
- Number Of Participants
- 1221
Sites
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncology
- Contact Person Name
- Delvis Rodríguez Abreu
- Contact Person Email
- delvysra@yahoo.com
- Site Name
- University Hospital Son Espases
- Department Name
- Oncology
- Contact Person Name
- Aitor Azkárate Martínez
- Contact Person Email
- aitor.azkarate@ssib.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Maria Jove Casulleras
- Contact Person Email
- mjove@iconcologia.net
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology
- Contact Person Name
- Marta López-Brea Piqueras
- Contact Person Email
- mlopez@humv.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Contact Person Name
- Paula Cerdá Serdà
- Contact Person Email
- pcerda@santpau.cat
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- Oncology
- Contact Person Name
- Encarnación Jiménez
- Contact Person Email
- encarji@yahoo.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Hematology
- Contact Person Name
- Ana Ruiz Casado
- Contact Person Email
- anaruizcasado@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- Amparo Sánchez Gastaldo
- Contact Person Email
- asanchezgastaldo@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Enriqueta Felip-Font
- Contact Person Email
- enriqueta.felip@vallhebron.cat
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Contact Person Name
- Javier García Corbacho
- Contact Person Email
- jgcorbacho@ibima.eu
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology
- Contact Person Name
- Jaime Feliu Battle
- Contact Person Email
- jaime.feliu@hotmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Contact Person Name
- Paloma Martín Martorell
- Contact Person Email
- paloma_martin@comv.es
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Oncology
- Contact Person Name
- Joaquim Bosch- Barrera
- Contact Person Email
- jbosch@iconcologia.net
- Site Name
- Micancer Center S.L.P.
- Department Name
- Oncology
- Contact Person Name
- Santiago Viteri Ramirez
- Contact Person Email
- sviteri@uomi.es
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Oncology
- Contact Person Name
- Andrés Aguilar Hernández
- Contact Person Email
- aaguilar@oncorosell.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Manuel Pedregal Trujillo
- Contact Person Email
- Manuel.Pedregal@startmadrid.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Contact Person Name
- Eduardo Castañón Alvarez
- Contact Person Email
- ecastanon@unav.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Maria Elisa Reig Monzon
- Contact Person Email
- mreig1@clinic.cat
- Site Name
- Hospital Universitario De Jaen
- Department Name
- Oncology
- Contact Person Name
- Francisco José García Verdejo
- Contact Person Email
- fjgverdejo@gmail.com
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Digestive
- Contact Person Name
- Alberto Lué
- Contact Person Email
- alue@salud.aragon.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Contact Person Name
- Oscar Juan Vidal
- Contact Person Email
- juan_osc@gva.es
Sponsor
Primary sponsor
- Full Name
- Tesaro Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- TSR-022
- Modality
- Monoclonal antibody
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