Clinical trial • Phase I • Oncology
Inhibitor of the enzyme glucosaminyltransferase V for Advanced or metastatic solid tumours
Phase I trial of Inhibitor of the enzyme glucosaminyltransferase V for Advanced or metastatic solid tumours. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced or metastatic solid tumours
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 06-09-2024
- First CTIS Authorization Date
- 15-10-2024
Trial design
None/Not specified-controlled Phase I trial across 5 sites in France, Italy.
- Comparator
- None/Not specified
- Target Sample Size
- 149
Eligibility
Recruits 149 Vulnerable population selected: true. No further details provided on vulnerable-population definitions, consent or assent handling in the available documentation..
- Vulnerable Population
- Vulnerable population selected: true. No further details provided on vulnerable-population definitions, consent or assent handling in the available documentation.
Recruitment
- Planned Sample Size
- 149
- Recruitment Window Months
- 72
- Consent Approach
- No information provided on informed consent, assent processes, age-specific consent documents, or languages available in the provided records.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 149
France
- Earliest CTIS Part Ii Submission Date
- 09-10-2024
- Latest Decision Or Authorization Date
- 12-03-2025
- Processing Time Days
- 154
- Number Of Sites
- 2
- Number Of Participants
- 40
Sites
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Contact Person Name
- Cécile Vicier
- Contact Person Email
- vicierc@ipc.unicancer.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Early Clinical Trial Unit - Medical Oncology
- Contact Person Name
- Diego Tosi
- Contact Person Email
- diego.tosi@icm.unicancer.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 25-09-2024
- Latest Decision Or Authorization Date
- 31-03-2025
- Processing Time Days
- 187
- Number Of Sites
- 3
- Number Of Participants
- 109
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Medical Oncology - Phase 1 Unit
- Contact Person Name
- Gianluca Del Conte
- Contact Person Email
- delconte.gianluca@hsr.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology I
- Contact Person Name
- Sara Cresta
- Contact Person Email
- sara.cresta@istitutotumori.mi.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Medical Oncology
- Contact Person Name
- Maria Pagano
- Contact Person Email
- maria.pagano@ausl.re.it
Sponsor
Primary sponsor
- Full Name
- Phost'In Therapeutics
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- PhOx430
- Active Substance
- Inhibitor of the enzyme glucosaminyltransferase V
- Modality
- Small molecule
- First In Class
- Yes
- First In Human
- Yes
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