Clinical trial • Phase I • Oncology
Clinical trial in Advanced solid tumors
Phase I trial for Advanced solid tumors. open-label, none/not specified-controlled, adaptive. 200 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 15-03-2025
- First CTIS Authorization Date
- 08-07-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 17 sites in France, Italy, Belgium and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True - dose escalation and expansion design; no specific adaptive rules, interim analyses or stopping rules provided in source
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 200
Eligibility
Recruits 200 Vulnerable population not selected; no special consent/assent handling described..
- Vulnerable Population
- Vulnerable population not selected; no special consent/assent handling described.
Recruitment
- Planned Sample Size
- 200
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 43
France
- Earliest CTIS Part Ii Submission Date
- 27-06-2025
- Latest Decision Or Authorization Date
- 08-07-2025
- Processing Time Days
- 11
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- 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
- Institut Paoli Calmettes
- Department Name
- Oncology
- Principal Investigator Name
- Cecile Vicier
- Principal Investigator Email
- vicierc@ipc.unicancer.fr
- Contact Person Name
- Cecile Vicier
- Contact Person Email
- vicierc@ipc.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP
- Principal Investigator Name
- Christophe Massard
- Principal Investigator Email
- christophe.massard@gustaveroussey.fr
- Contact Person Name
- Christophe Massard
- Contact Person Email
- christophe.massard@gustaveroussey.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical
- Principal Investigator Name
- Marie Robert
- Principal Investigator Email
- marie.robert@ico.unicancer.fr
- Contact Person Name
- Marie Robert
- Contact Person Email
- marie.robert@ico.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Armelle Vinceneux
- Principal Investigator Email
- armelle.vinceneux@lyon.unicancer.fr
- Contact Person Name
- Armelle Vinceneux
- Contact Person Email
- armelle.vinceneux@lyon.unicancer.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 23-06-2025
- Latest Decision Or Authorization Date
- 08-07-2025
- Processing Time Days
- 15
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncology
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simonelli@cancercenter.humanitas.it
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@cancercenter.humanitas.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncology
- Principal Investigator Name
- Andrea Necchi
- Principal Investigator Email
- necchi.andrea@hsr.it
- Contact Person Name
- Andrea Necchi
- Contact Person Email
- necchi.andrea@hsr.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncology
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 04-12-2025
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 19
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Az Maria Middelares Gent
- Department Name
- Medical Oncology & hematology
- Principal Investigator Name
- Christof Vulsteke
- Principal Investigator Email
- christof.vulsteke@mijnziekenhuis.be
- Contact Person Name
- Christof Vulsteke
- Contact Person Email
- christof.vulsteke@mijnziekenhuis.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Urology
- Principal Investigator Name
- Karl Lesage
- Principal Investigator Email
- karl.lesage@azgroeninge.be
- Contact Person Name
- Karl Lesage
- Contact Person Email
- karl.lesage@azgroeninge.be
- Site Name
- Institut Jules Bordet
- Department Name
- Oncology
- Principal Investigator Name
- Nuria Kotecki
- Principal Investigator Email
- nuria.kotecki@hubruxelles.be
- Contact Person Name
- Nuria Kotecki
- Contact Person Email
- nuria.kotecki@hubruxelles.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Oncology
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
Spain
- Earliest CTIS Part Ii Submission Date
- 10-06-2025
- Latest Decision Or Authorization Date
- 20-01-2026
- Processing Time Days
- 224
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Centro Integral Oncológico Clara Campall (CIOCC) Phase I trials unit
- Principal Investigator Name
- Juan Francisco Rodriguez Moreno
- Principal Investigator Email
- juanfran.rodriguez@startmadrid.com
- Contact Person Name
- Juan Francisco Rodriguez Moreno
- Contact Person Email
- juanfran.rodriguez@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jaume Capdevila Castillon
- Principal Investigator Email
- jcapdevila@vhio.net
- Contact Person Name
- Jaume Capdevila Castillon
- Contact Person Email
- jcapdevila@vhio.net
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- NEXT Madrid Phase I trials
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Phase Unit I
- Principal Investigator Name
- Fabriccio Racca
- Principal Investigator Email
- fracca@nextoncology.eu
- Contact Person Name
- Fabriccio Racca
- Contact Person Email
- fracca@nextoncology.eu
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Begoña Mellado
- Principal Investigator Email
- BMELLADO@clinic.cat
- Contact Person Name
- Begoña Mellado
- Contact Person Email
- BMELLADO@clinic.cat
Sponsor
Primary sponsor
- Full Name
- Synnovation Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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