Clinical trial • Phase I • Oncology
TSR-042 (anti-PD-1 monoclonal antibody) for Advanced solid tumors
Phase I trial of TSR-042 (anti-PD-1 monoclonal antibody) for Advanced solid tumors. None/Not specified-controlled, adaptive. 425 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
- 12-02-2024
- First CTIS Authorization Date
- 18-03-2024
Trial design
None/Not specified-controlled, adaptive Phase I trial in Czechia, Italy, Poland and others.
- Comparator
- None/Not specified
- Adaptive
- True, study includes dose-escalation and cohort-expansion design (no further adaptive elements or rules provided)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 425
Eligibility
Recruits 425 isVulnerablePopulationSelected is true; no further details on consent or assent handling provided in the record..
- Vulnerable Population
- isVulnerablePopulationSelected is true; no further details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 425
- Recruitment Window Months
- 139
Geography
- Total Number Of Sites
- 44
- Total Number Of Participants
- 520
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 719
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Krajska Nemocnice T Bati a.s.
- Department Name
- Komplexní onkologické centrum (Comprehensive Oncology Center)
- Principal Investigator Name
- Markéta Pospíšková
- Principal Investigator Email
- pospiskova@bnzlin.cz
- Contact Person Name
- Markéta Pospíšková
- Contact Person Email
- pospiskova@bnzlin.cz
Italy
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 365
- Number Of Sites
- 5
- Number Of Participants
- 55
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Dipartimento di Oncologia Medica Settore Q - 1° piano
- Principal Investigator Name
- Gianluca Del Conte
- Principal Investigator Email
- delconte.gianluca@hsr.it
- Contact Person Name
- Gianluca Del Conte
- Contact Person Email
- delconte.gianluca@hsr.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- SC Sperimentazioni Cliniche
- Principal Investigator Name
- Adriano Gravina
- Principal Investigator Email
- a.gravina@istitutotumori.na.it
- Contact Person Name
- Adriano Gravina
- Contact Person Email
- a.gravina@istitutotumori.na.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Filippo De Braud
- Principal Investigator Email
- filippo.debraud@istitutotumori.mi.it
- Contact Person Name
- Filippo De Braud
- Contact Person Email
- filippo.debraud@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Struttura complessa di Oncologia
- Principal Investigator Name
- Annalisa Fontana
- Principal Investigator Email
- fontana.annalisa@aou.mo.it
- Contact Person Name
- Annalisa Fontana
- Contact Person Email
- fontana.annalisa@aou.mo.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
Poland
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 22-02-2026
- Processing Time Days
- 721
- Number Of Sites
- 4
- Number Of Participants
- 130
Sites
- Site Name
- Szpitale Pomorskie Sp. z o.o.
- Department Name
- Oddział Onkologii i Radioterapii
- Principal Investigator Name
- Joanna Pikiel
- Principal Investigator Email
- joanna.pikiel@post.pl
- Contact Person Name
- Joanna Pikiel
- Contact Person Email
- joanna.pikiel@post.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oddział Badań Wczesnych Faz
- Principal Investigator Name
- Iwona Ługowska
- Principal Investigator Email
- iwona.lugowska@pibnio.pl
- Contact Person Name
- Iwona Ługowska
- Contact Person Email
- iwona.lugowska@pibnio.pl
- Site Name
- Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
- Department Name
- Oddział Chemioterapii Nowotworów
- Principal Investigator Name
- Piotr Sawrycki
- Principal Investigator Email
- piotrsaw@am.torun.pl
- Contact Person Name
- Piotr Sawrycki
- Contact Person Email
- piotrsaw@am.torun.pl
- Site Name
- Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o.
- Department Name
- Chemotherapy Clinic
- Principal Investigator Name
- Małgorzata Suszko-Każarnowicz
- Principal Investigator Email
- malgorzata_ol@onet.eu
- Contact Person Name
- Małgorzata Suszko-Każarnowicz
- Contact Person Email
- malgorzata_ol@onet.eu
France
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 718
- Number Of Sites
- 10
- Number Of Participants
- 129
Sites
- Site Name
- Centre Oscar Lambret
- Department Name
- Département de Cancérologie Gynécologie
- Principal Investigator Name
- Cyril ABDEDDAIM
- Principal Investigator Email
- c-abdeddaim@o-lambret.fr
- Contact Person Name
- Cyril ABDEDDAIM
- Contact Person Email
- c-abdeddaim@o-lambret.fr
- Site Name
- Centre Jean Perrin
- Principal Investigator Name
- Xavier Durando
- Principal Investigator Email
- xavier.durando@clermont.unicancer.fr
- Contact Person Name
- Xavier Durando
- Contact Person Email
- xavier.durando@clermont.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Service d'Oncologie Médicale
- Principal Investigator Name
- Dominique Berton
- Principal Investigator Email
- dominique.berton@ico.unicancer.fr
- Contact Person Name
- Dominique Berton
- Contact Person Email
- dominique.berton@ico.unicancer.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- SC Sperimentazioni Cliniche
- Principal Investigator Name
- Renaud SABATIER
- Principal Investigator Email
- sabatierr@ipc.unicancer.fr
- Contact Person Name
- Renaud SABATIER
- Contact Person Email
- sabatierr@ipc.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d’Oncologie Médicale
- Principal Investigator Name
- Jacques Medioni
- Principal Investigator Email
- Jacques.medioni@aphp.fr
- Contact Person Name
- Jacques Medioni
- Contact Person Email
- Jacques.medioni@aphp.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Service d’Hépato Gastroentérologie
- Principal Investigator Name
- Thibaud Reverdy
- Principal Investigator Email
- thibaut.reverdy@chu-lyon.fr
- Contact Person Name
- Thibaud Reverdy
- Contact Person Email
- thibaut.reverdy@chu-lyon.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Département d’Innovation Thérapeutique et des Essais Précoses
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@igr.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@igr.fr
- Site Name
- Institut Bergonie
- Department Name
- Départment D'Oncologie Médicale
- Principal Investigator Name
- Antoine Italiano
- Principal Investigator Email
- a.italiano@bordeaux.unicancer.fr
- Contact Person Name
- Antoine Italiano
- Contact Person Email
- a.italiano@bordeaux.unicancer.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Département de Médecine Oncologique
- Principal Investigator Name
- Florence Joly
- Principal Investigator Email
- f.joly@baclesse.unicancer.fr
- Contact Person Name
- Florence Joly
- Contact Person Email
- f.joly@baclesse.unicancer.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Service d’Oncologie médicale
- Principal Investigator Name
- Thierry Andre
- Principal Investigator Email
- thierry.andre@aphp.fr
- Contact Person Name
- Thierry Andre
- Contact Person Email
- thierry.andre@aphp.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 18-03-2024
- Processing Time Days
- 384
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Rigshospitalet
- Department Name
- Dept. of Oncology 5073
- Principal Investigator Name
- Trine Jakobi Noettrup
- Principal Investigator Email
- trine.jakobi.noettrup@regionh.dk
- Contact Person Name
- Trine Jakobi Noettrup
- Contact Person Email
- trine.jakobi.noettrup@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 381
- Number Of Sites
- 23
- Number Of Participants
- 194
Sites
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Oncology Department
- Principal Investigator Name
- Juan Rafael De la Haba Rodriguez
- Principal Investigator Email
- jrhaba@uco.es
- Contact Person Name
- Juan Rafael De la Haba Rodriguez
- Contact Person Email
- jrhaba@uco.es
- Site Name
- Hospital Universitario De Jaen
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Ana Laura Ortega Granados
- Principal Investigator Email
- oncojaen@fibao.es
- Contact Person Name
- Ana Laura Ortega Granados
- Contact Person Email
- oncojaen@fibao.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology Department
- Principal Investigator Name
- Ignacio Jose Duran Martinez
- Principal Investigator Email
- ignaciojose.duran@scsalud.es
- Contact Person Name
- Ignacio Jose Duran Martinez
- Contact Person Email
- ignaciojose.duran@scsalud.es
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Antonio Antón Torres
- Principal Investigator Email
- aantont@salud.aragon.es
- Contact Person Name
- Antonio Antón Torres
- Contact Person Email
- aantont@salud.aragon.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology Service Department
- Principal Investigator Name
- Maria Pilar Barretina Ginesta
- Principal Investigator Email
- mpbarretina@iconcologia.ne
- Contact Person Name
- Maria Pilar Barretina Ginesta
- Contact Person Email
- mpbarretina@iconcologia.ne
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology Service Department
- Principal Investigator Name
- Desamparados Roda
- Principal Investigator Email
- derope@hotmail.com
- Contact Person Name
- Desamparados Roda
- Contact Person Email
- derope@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology Department
- Principal Investigator Name
- Alejandro Falcon Gonzalez
- Principal Investigator Email
- alejandro.falcon.sspa@juntadeandalucia.es
- Contact Person Name
- Alejandro Falcon Gonzalez
- Contact Person Email
- alejandro.falcon.sspa@juntadeandalucia.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Ivan Victoria Ruiz
- Principal Investigator Email
- ivictori@recerca.clinic.cat
- Contact Person Name
- Ivan Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Rafael Lopez Lopez
- Principal Investigator Email
- Rafael.lopez.lopez@sergas.es
- Contact Person Name
- Rafael Lopez Lopez
- Contact Person Email
- Rafael.lopez.lopez@sergas.es
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology Department
- Principal Investigator Name
- Javier Sastre
- Principal Investigator Email
- jsastrev@salud.madrid.org
- Contact Person Name
- Javier Sastre
- Contact Person Email
- jsastrev@salud.madrid.org
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology Department
- Principal Investigator Name
- Irene Moreno Candilejo
- Principal Investigator Email
- irene.moreno@startmadrid.com
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology Department
- Principal Investigator Name
- Andres Redondo
- Principal Investigator Email
- andres.redondo@salud.madrid.org
- Contact Person Name
- Andres Redondo
- Contact Person Email
- andres.redondo@salud.madrid.org
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Oncology Department
- Principal Investigator Name
- Serafin Morales Murillo
- Principal Investigator Email
- smorales.lleida.ics@gencat.cat
- Contact Person Name
- Serafin Morales Murillo
- Contact Person Email
- smorales.lleida.ics@gencat.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- David Páez López-Bravo
- Principal Investigator Email
- dpaez@santpau.cat
- Contact Person Name
- David Páez López-Bravo
- Contact Person Email
- dpaez@santpau.cat
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Oncology Department
- Principal Investigator Name
- Jeronimo Martinez Garcia
- Principal Investigator Email
- jeronimo@seom.org
- Contact Person Name
- Jeronimo Martinez Garcia
- Contact Person Email
- jeronimo@seom.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology Department
- Principal Investigator Name
- Lorena Fariñas Madrid
- Principal Investigator Email
- lfarinas@vhio.net
- Contact Person Name
- Lorena Fariñas Madrid
- Contact Person Email
- lfarinas@vhio.net
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Javier García Corbacho
- Principal Investigator Email
- jgcorbacho@ibima.eu
- Contact Person Name
- Javier García Corbacho
- Contact Person Email
- jgcorbacho@ibima.eu
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology Department
- Principal Investigator Name
- Eduardo Castanon Alvarez
- Principal Investigator Email
- ecastanon@unav.es
- Contact Person Name
- Eduardo Castanon Alvarez
- Contact Person Email
- ecastanon@unav.es
- Site Name
- Institut Catala D'oncologia (L'Hospitalet De Llobregat)
- Department Name
- Oncology Department
- Principal Investigator Name
- Marta Gil Martin
- Principal Investigator Email
- mgilmartin@iconcologia.net
- Contact Person Name
- Marta Gil Martin
- Contact Person Email
- mgilmartin@iconcologia.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology Department
- Principal Investigator Name
- Victor Moreno Garcia
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology Department
- Principal Investigator Name
- Angel Luis Guerrero Zotano
- Principal Investigator Email
- aguerrero@fivo.org
- Contact Person Name
- Angel Luis Guerrero Zotano
- Contact Person Email
- aguerrero@fivo.org
Sponsor
Primary sponsor
- Full Name
- Tesaro Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- TSR-042
- Active Substance
- TSR-042 (anti-PD-1 monoclonal antibody)
- Modality
- Monoclonal antibody
Related trials
Other published trials that may interest you.