Clinical trial • Phase I • Oncology
INCB123667 for Advanced or metastatic solid tumors
Phase I trial of INCB123667 for Advanced or metastatic solid tumors. open-label, none/not specified-controlled. 369 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced or metastatic solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 21-05-2024
- First CTIS Authorization Date
- 21-06-2024
Trial design
open-label, none/not specified-controlled Phase I trial across 11 sites in France, Italy, Netherlands.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 369
Recruitment
- Planned Sample Size
- 369
- Recruitment Window Months
- 48
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 235
France
- Earliest CTIS Part Ii Submission Date
- 26-03-2024
- Latest Decision Or Authorization Date
- 25-06-2024
- Processing Time Days
- 91
- Number Of Sites
- 4
- Number Of Participants
- 50
Sites
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Medical Oncology
- Principal Investigator Name
- Carlos Gomez-Roca
- Principal Investigator Email
- gomez-roca.carlos@iuct-oncopole.fr
- Contact Person Name
- Carlos Gomez-Roca
- Contact Person Email
- gomez-roca.carlos@iuct-oncopole.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- 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
- Institut Gustave Roussy
- Department Name
- Department of Medicine
- Principal Investigator Name
- Kaïssa Ouali
- Principal Investigator Email
- kaissa.ouali@gustaveroussy.fr
- Contact Person Name
- Kaïssa Ouali
- Contact Person Email
- kaissa.ouali@gustaveroussy.fr
- 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
Italy
- Earliest CTIS Part Ii Submission Date
- 26-03-2024
- Latest Decision Or Authorization Date
- 09-09-2024
- Processing Time Days
- 167
- Number Of Sites
- 5
- Number Of Participants
- 160
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncology and Hematology
- 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
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Oncology
- Principal Investigator Name
- Davide Melisi
- Principal Investigator Email
- davide.melisi@univr.it
- Contact Person Name
- Davide Melisi
- Contact Person Email
- davide.melisi@univr.it
- Site Name
- Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Silvia Damian
- Principal Investigator Email
- silvia.damian@istitutotumori.mi.it
- Contact Person Name
- Silvia Damian
- Contact Person Email
- silvia.damian@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Gynecologic Oncology Unit
- Principal Investigator Name
- Vanda Salutari
- Principal Investigator Email
- vanda.salutari@policlinicogemelli.it
- Contact Person Name
- Vanda Salutari
- Contact Person Email
- vanda.salutari@policlinicogemelli.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Fase 1
- Principal Investigator Name
- Gennaro Daniele
- Principal Investigator Email
- gennaro.daniele@policlinogemelli.it
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinogemelli.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 26-03-2024
- Latest Decision Or Authorization Date
- 21-06-2024
- Processing Time Days
- 87
- Number Of Sites
- 2
- Number Of Participants
- 25
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ingrid Boere
- Principal Investigator Email
- i.boere@erasmusmc.nl
- Contact Person Name
- Ingrid Boere
- Contact Person Email
- i.boere@erasmusmc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Internal Oncology
- Principal Investigator Name
- Frans Opdam
- Principal Investigator Email
- f.opdam@nki.nl
- Contact Person Name
- Frans Opdam
- Contact Person Email
- f.opdam@nki.nl
Sponsor
Primary sponsor
- Full Name
- Incyte Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- INCB123667
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.