Clinical trial • Phase I • Oncology
MBS8(1V270) for Advanced solid tumors
Phase I trial of MBS8(1V270) for Advanced solid tumors. open-label, adaptive. 103 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 08-03-2024
- First CTIS Authorization Date
- 09-04-2024
Trial design
open-label, adaptive Phase I trial across 8 sites in Belgium, Spain, Denmark.
- Open Label
- Yes
- Adaptive
- True, dose-escalation design (phase I); specific escalation rules or stopping rules not provided in available documents
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 103
Recruitment
- Planned Sample Size
- 103
- Recruitment Window Months
- 71
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 103
Belgium
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 692
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Oncology
- Principal Investigator Name
- Nuria Kotecki
- Principal Investigator Email
- p-a.bouchonville@hubruxelles.be
- Contact Person Name
- Nuria Kotecki
- Contact Person Email
- p-a.bouchonville@hubruxelles.be
Spain
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 692
- Number Of Sites
- 5
- Number Of Participants
- 43
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Josep M Piulats
- Principal Investigator Email
- jmpiulats@iconcologia.net
- Contact Person Name
- Josep M Piulats
- Contact Person Email
- jmpiulats@iconcologia.net
- Site Name
- Consorcio Hospital General Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Alfonso Berrocal Jaime
- Principal Investigator Email
- berrocal.alf@gmail.com
- Contact Person Name
- Alfonso Berrocal Jaime
- Contact Person Email
- berrocal.alf@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Victor Moreno
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Principal Investigator Name
- Tatiana Hernandez Guerrero
- Principal Investigator Email
- Tatiana.hernandez@start-barcelona.com
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- Tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Emiliano Calvo
- Principal Investigator Email
- emiliano.calvo@startmadrid.com
- Contact Person Name
- Emiliano Calvo
- Contact Person Email
- emiliano.calvo@startmadrid.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 688
- Number Of Sites
- 2
- Number Of Participants
- 40
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Oncology
- Principal Investigator Name
- Rikke Lovendahl Eefsen
- Principal Investigator Email
- rikke.helene.loevendahl.eefsen@regionh.dk
- Contact Person Name
- Rikke Lovendahl Eefsen
- Contact Person Email
- rikke.helene.loevendahl.eefsen@regionh.dk
- Site Name
- Rigshospitalet
- Department Name
- Oncology
- Principal Investigator Name
- Kristoffer Staal Rohrberg
- Principal Investigator Email
- kristoffer.staal.rohrberg@regionh.dk
- Contact Person Name
- Kristoffer Staal Rohrberg
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
Sponsor
Primary sponsor
- Full Name
- MonTa Biosciences ApS
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Investigational products
- Investigational Product Name
- MBS8(1V270)
- Routes Of Administration
- Intravenous
- Route
- Intravenous
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