Clinical trial • Phase I • Oncology|Dermatology
MB097 for Advanced melanoma|Malignant melanoma
Phase I trial of MB097 for Advanced melanoma|Malignant melanoma. Randomised, open-label. 27 participants.
Overview
- Trial Therapeutic Area
- Oncology|Dermatology
- Trial Disease
- Advanced melanoma|Malignant melanoma
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 28-03-2024
- First CTIS Authorization Date
- 22-07-2024
Trial design
Randomised, open-label Phase I trial across 12 sites in France, Italy, Spain.
- Randomised
- Yes
- Open Label
- Yes
- Target Sample Size
- 27
- Trial Duration For Participant
- 1022
Eligibility
Recruits 27 isVulnerablePopulationSelected: true; no details on consent or assent handling provided in the record..
- Vulnerable Population
- isVulnerablePopulationSelected: true; no details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 27
- Recruitment Window Months
- 34
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 27
France
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 637
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Laurent MORTIER
- Principal Investigator Email
- laurent.mortier@chru-lille.fr
- Contact Person Name
- Laurent MORTIER
- Contact Person Email
- laurent.mortier@chru-lille.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Dermatology
- Principal Investigator Name
- Stéphane DALLE
- Principal Investigator Email
- stephane.dalle@chu-lyon.fr
- Contact Person Name
- Stéphane DALLE
- Contact Person Email
- stephane.dalle@chu-lyon.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM-CLIPP)
- Principal Investigator Name
- Caroline GAUDY
- Principal Investigator Email
- caroline.gaudy@ap-hm.fr
- Contact Person Name
- Caroline GAUDY
- Contact Person Email
- caroline.gaudy@ap-hm.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alice HERVIEU
- Principal Investigator Email
- ahervieu@cgfl.fr
- Contact Person Name
- Alice HERVIEU
- Contact Person Email
- ahervieu@cgfl.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Eve-Marie NEIDHARDT
- Principal Investigator Email
- evemarie.neidhardt@lyon.unicancer.fr
- Contact Person Name
- Eve-Marie NEIDHARDT
- Contact Person Email
- evemarie.neidhardt@lyon.unicancer.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 617
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Operative Unit of Oncology and Hematology
- Principal Investigator Name
- Armando Santoro
- Principal Investigator Email
- armando.santoro@cancercenter.humanitas.it
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@cancercenter.humanitas.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Melanoma. Cancer Immunotherapy and Development Therapeutics Unit
- Principal Investigator Name
- Paolo Antonio Ascierto
- Principal Investigator Email
- p.ascierto@istitutotumori.na.it
- Contact Person Name
- Paolo Antonio Ascierto
- Contact Person Email
- p.ascierto@istitutotumori.na.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Sviluppo di nuovi farmaci per terapie innovative
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 670
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Guillermo Antonio de Velasco Oria de Rueda
- Principal Investigator Email
- unidaddigestivo.imas12@h12o.es
- Contact Person Name
- Guillermo Antonio de Velasco Oria de Rueda
- Contact Person Email
- unidaddigestivo.imas12@h12o.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Irene Moreno Candilejo
- Principal Investigator Email
- irene.moreno@startmadrid.com
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- 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 Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Ainara Soria
- Principal Investigator Email
- ainarasoria@hotmail.com
- Contact Person Name
- Ainara Soria
- Contact Person Email
- ainarasoria@hotmail.com
Sponsor
Primary sponsor
- Full Name
- Microbiotica Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- MB097
- Active Substance
- MB097
- Investigational Product Name
- Pembrolizumab
- Active Substance
- Pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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