Clinical trial • Phase I • Oncology
OKI-219 for Advanced solid tumors|Advanced breast cancer
Phase I trial of OKI-219 for Advanced solid tumors|Advanced breast cancer. 213 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors|Advanced breast cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 18-01-2024
- First CTIS Authorization Date
- 18-04-2024
Trial design
Phase I trial across 23 sites in Belgium, France, Italy and others.
- Target Sample Size
- 213
Eligibility
Recruits 213 Vulnerable population selected; no further details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 213
- Recruitment Window Months
- 42
- Consent Approach
- Not specified in record.
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 145
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-03-2024
- Latest Decision Or Authorization Date
- 29-01-2026
- Processing Time Days
- 674
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- MEDICAL ONCOLOGY/ HEAD OF CTCU
- Principal Investigator Name
- Philippe Aftimos
- Principal Investigator Email
- philippe.aftimos@hubruxelles.be
- Contact Person Name
- Philippe Aftimos
- Contact Person Email
- philippe.aftimos@hubruxelles.be
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- Oncology
- Principal Investigator Name
- Tom Van Den Mooter
- Principal Investigator Email
- tom.vandenmooter@gza.be
- Contact Person Name
- Tom Van Den Mooter
- Contact Person Email
- tom.vandenmooter@gza.be
- Site Name
- UZ Leuven
- Department Name
- Oncology
- Principal Investigator Name
- Hans Wildiers
- Principal Investigator Email
- Hans.wildiers@uzleuven.be
- Contact Person Name
- Hans Wildiers
- Contact Person Email
- Hans.wildiers@uzleuven.be
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Konstantinos Papadimitriou
- Principal Investigator Email
- Konstantinos.papadimitriou@uza.be
- Contact Person Name
- Konstantinos Papadimitriou
- Contact Person Email
- Konstantinos.papadimitriou@uza.be
France
- Earliest CTIS Part Ii Submission Date
- 23-11-2023
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 797
- Number Of Sites
- 6
- Number Of Participants
- 70
Sites
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Early Phase unit_Medical Oncology Department
- Principal Investigator Name
- Jean-David FUMET
- Principal Investigator Email
- jdfumet@cgfl.fr
- Contact Person Name
- Jean-David FUMET
- Contact Person Email
- jdfumet@cgfl.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Philippe FOLLANA
- Principal Investigator Email
- Philippe.FOLLANA@nice.unicancer.fr
- Contact Person Name
- Philippe FOLLANA
- Contact Person Email
- Philippe.FOLLANA@nice.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Philippe CASSIER
- Principal Investigator Email
- Philippe.cassier@lyon.unicancer.fr
- Contact Person Name
- Philippe CASSIER
- Contact Person Email
- Philippe.cassier@lyon.unicancer.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Benoit YOU
- Principal Investigator Email
- benoit.you@chu-lyon.fr
- Contact Person Name
- Benoit YOU
- Contact Person Email
- benoit.you@chu-lyon.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medicine
- Principal Investigator Name
- Barbara PISTILLI
- Principal Investigator Email
- BARBARA.PISTILLI@gustaveroussy.fr
- Contact Person Name
- Barbara PISTILLI
- Contact Person Email
- BARBARA.PISTILLI@gustaveroussy.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Loic LEBELLEC
- Principal Investigator Email
- l-lebellec@o-lambret.fr
- Contact Person Name
- Loic LEBELLEC
- Contact Person Email
- l-lebellec@o-lambret.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 673
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Phase I Research Center
- Principal Investigator Name
- Marina Elena Cazzaniga
- Principal Investigator Email
- marinaelena.cazzaniga@irccs-sangerardo.it
- Contact Person Name
- Marina Elena Cazzaniga
- Contact Person Email
- marinaelena.cazzaniga@irccs-sangerardo.it
- Site Name
- Istituto Europeo Di Oncologia 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
- Site Name
- Humanitas Research Hospital
- Department Name
- Phase I Unit
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simonelli@hunimed.eu
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@hunimed.eu
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UO Oncologia Medica
- 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
- Azienda Ospedaliera Universitaria Senese
- Department Name
- UOC Immunoterapia oncologica
- Principal Investigator Name
- Michele Maio
- Principal Investigator Email
- mmaiocro@gmail.com
- Contact Person Name
- Michele Maio
- Contact Person Email
- mmaiocro@gmail.com
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology and Hematology
- Principal Investigator Name
- Sara Cresta
- Principal Investigator Email
- sara.cresta@istitutotumori.mi.it
- Contact Person Name
- Sara Cresta
- Contact Person Email
- sara.cresta@istitutotumori.mi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 29-01-2026
- Processing Time Days
- 673
- Number Of Sites
- 7
- Number Of Participants
- 37
Sites
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Medical Oncology
- Principal Investigator Name
- Roberto Martin Huertas
- Principal Investigator Email
- roberto.martin@startresearch.com
- Contact Person Name
- Roberto Martin Huertas
- Contact Person Email
- roberto.martin@startresearch.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Phase I Trials Unit
- Principal Investigator Name
- Ramón Yarza Barrio
- Principal Investigator Email
- Ramon.yarza@startmadrid.com
- Contact Person Name
- Ramón Yarza Barrio
- Contact Person Email
- Ramon.yarza@startmadrid.com
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Next Oncology. IOB
- Principal Investigator Name
- Fabricio Racca Bussano
- Principal Investigator Email
- fracca@nextoncology.eu
- Contact Person Name
- Fabricio Racca Bussano
- Contact Person Email
- fracca@nextoncology.eu
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jesus Fuentes Antras
- Principal Investigator Email
- jfuentesantras@nextoncology.eu
- Contact Person Name
- Jesus Fuentes Antras
- Contact Person Email
- jfuentesantras@nextoncology.eu
- Site Name
- Hospital Beata Maria Ana
- Department Name
- IOB Madrid Institute of Oncology
- Principal Investigator Name
- Javier Cortes Castan
- Principal Investigator Email
- jacortes@vhio.net
- Contact Person Name
- Javier Cortes Castan
- Contact Person Email
- jacortes@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jon Zugazagoitia Fraile
- Principal Investigator Email
- j.zugazagoitia.imas12@h12o.es
- Contact Person Name
- Jon Zugazagoitia Fraile
- Contact Person Email
- j.zugazagoitia.imas12@h12o.es
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Medical Oncology
- 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
Sponsor
Primary sponsor
- Full Name
- Onkure Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- OKI-219
- First In Human
- Yes
- Combination Treatment
- Yes
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