Clinical trial • Phase I • Oncology
Mesothelin x CD47 bispecific antibody for Mesothelin-expressing solid tumours
Phase I trial of Mesothelin x CD47 bispecific antibody for Mesothelin-expressing solid tumours. 106 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Mesothelin-expressing solid tumours
- Trial Stage
- Phase I
- Drug Modality
- Bispecific antibody | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 11-10-2024
- First CTIS Authorization Date
- 05-11-2024
Trial design
Phase I trial across 9 sites in France, Italy, Spain.
- Biomarker Stratified
- True, biomarker: mesothelin expression
- Target Sample Size
- 106
Eligibility
Recruits 106 Vulnerable population flag is set (isVulnerablePopulationSelected = true) in the record; no further details on consent/assent handling are provided..
- Vulnerable Population
- Vulnerable population flag is set (isVulnerablePopulationSelected = true) in the record; no further details on consent/assent handling are provided.
Recruitment
- Planned Sample Size
- 106
- Recruitment Window Months
- 71
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 106
France
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 05-11-2024
- Processing Time Days
- 13
- Number Of Sites
- 4
- Number Of Participants
- 66
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Centre d'Essais Précoces en Cancérologie (CEPEC). Centre Expert Cancer du Sein
- Principal Investigator Name
- Jacques Medioni
- Principal Investigator Email
- jacques.medioni@aphp.fr
- Contact Person Name
- Jacques Medioni
- Contact Person Email
- jacques.medioni@aphp.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Service d'oncologie médicale
- Principal Investigator Name
- Thibault De La Motte Rouge
- Principal Investigator Email
- t.delamotterouge@rennes.unicancer.fr
- Contact Person Name
- Thibault De La Motte Rouge
- Contact Person Email
- t.delamotterouge@rennes.unicancer.fr
- Site Name
- Institut Curie
- Department Name
- Site de Recherche Intégrée sur le Cancer
- Principal Investigator Name
- Emanuela Romano
- Principal Investigator Email
- emanuela.romano@curie.fr
- Contact Person Name
- Emanuela Romano
- Contact Person Email
- emanuela.romano@curie.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Drug Development Department
- Principal Investigator Name
- Kaissa Ouali
- Principal Investigator Email
- kaissa.ouali@gustaveroussy.fr
- Contact Person Name
- Kaissa Ouali
- Contact Person Email
- kaissa.ouali@gustaveroussy.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 11-11-2024
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 25
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Matteo Simonelli
- Principal Investigator Email
- matteo.simonelli@cancercenter.humanitas.it
- Contact Person Name
- Matteo Simonelli
- Contact Person Email
- matteo.simonelli@cancercenter.humanitas.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Dipartimento di Oncologia ed Emato-Oncologia
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Andrea Zivi
- Principal Investigator Email
- andrea.zivi@aovr.veneto.it
- Contact Person Name
- Andrea Zivi
- Contact Person Email
- andrea.zivi@aovr.veneto.it
Spain
- Earliest CTIS Part Ii Submission Date
- 13-05-2025
- Latest Decision Or Authorization Date
- 23-05-2025
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Lorena Fariñas
- Principal Investigator Email
- lfarinas@vhio.net
- Contact Person Name
- Lorena Fariñas
- Contact Person Email
- lfarinas@vhio.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Antonio González Martín
- Principal Investigator Email
- agonzalezma@unav.es
- Contact Person Name
- Antonio González Martín
- Contact Person Email
- agonzalezma@unav.es
Sponsor
Primary sponsor
- Full Name
- NovImmune S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- NI-1801
- Active Substance
- Mesothelin x CD47 bispecific antibody
- Modality
- Bispecific antibody
- Investigational Product Name
- Anti-PD-1 antibody
- Active Substance
- Anti-PD-1 monoclonal antibody (unspecified)
- Modality
- Monoclonal antibody
- Investigational Product Name
- Paclitaxel
- Active Substance
- Paclitaxel
- Modality
- Small molecule
- Investigational Product Name
- Bevacizumab
- Active Substance
- Bevacizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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