Clinical trial • Phase I • Oncology
M3554 (Anti-GD2 ADC) for Advanced solid tumors|Soft tissue sarcoma|Glioblastoma
Phase I trial of M3554 (Anti-GD2 ADC) for Advanced solid tumors|Soft tissue sarcoma|Glioblastoma. None/Not specified-controlled. 26 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors|Soft tissue sarcoma|Glioblastoma
- Trial Stage
- Phase I
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 31-07-2024
- First CTIS Authorization Date
- 26-11-2024
Trial design
None/Not specified-controlled Phase I trial across 5 sites in Belgium, France.
- Comparator
- None/Not specified
- Target Sample Size
- 26
Eligibility
Recruits 26 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in the available documents..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling provided in the available documents.
Recruitment
- Planned Sample Size
- 26
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 26
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-10-2024
- Latest Decision Or Authorization Date
- 26-11-2024
- Processing Time Days
- 47
- Number Of Sites
- 1
- Number Of Participants
- 13
Sites
- Site Name
- UZ Leuven
- Department Name
- General Medical Oncology
- Principal Investigator Name
- Patrick Schöffski
- Principal Investigator Email
- patrick.schoffski@uzleuven.be
- Contact Person Name
- Patrick Schöffski
- Contact Person Email
- patrick.schoffski@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 04-11-2024
- Latest Decision Or Authorization Date
- 27-11-2024
- Processing Time Days
- 23
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Esma Saada-Bouzid
- Principal Investigator Email
- esma.saada-bouzid@nice.unicancer.fr
- Contact Person Name
- Esma Saada-Bouzid
- Contact Person Email
- esma.saada-bouzid@nice.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Loïc Lebellec
- Principal Investigator Email
- l-lebellec@o-lambret.fr
- Contact Person Name
- Loïc Lebellec
- Contact Person Email
- l-lebellec@o-lambret.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Mehdi Brahmi
- Principal Investigator Email
- mehdi.brahmi@lyon.unicancer.fr
- Contact Person Name
- Mehdi Brahmi
- Contact Person Email
- mehdi.brahmi@lyon.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Florent Peyraud
- Principal Investigator Email
- f.peyraud@bordeaux.unicancer.fr
- Contact Person Name
- Florent Peyraud
- Contact Person Email
- f.peyraud@bordeaux.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Merck Healthcare KGaA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- M3554 (Anti-GD2 ADC)
- Modality
- ADC
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