Clinical trial • Phase I • Oncology
BNT116 for Advanced non-small cell lung cancer
Phase I trial of BNT116 for Advanced non-small cell lung cancer. 157 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced non-small cell lung cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 19-12-2023
- First CTIS Authorization Date
- 01-02-2024
Trial design
Phase I trial across 18 sites in Germany, Hungary, Poland and others.
- Target Sample Size
- 157
Recruitment
- Planned Sample Size
- 157
- Recruitment Window Months
- 100
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 156
Germany
- Earliest CTIS Part Ii Submission Date
- 18-01-2024
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 670
- Number Of Sites
- 4
- Number Of Participants
- 27
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik I für Innere Medizin
- Principal Investigator Name
- Jürgen Wolf
- Principal Investigator Email
- juergen.wolf@uk-koeln.de
- Contact Person Name
- Jürgen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- Klinik für Onkologie und Hämatologie
- Principal Investigator Name
- Akin Atmaca
- Principal Investigator Email
- atmaca.akin@khnw.de
- Contact Person Name
- Akin Atmaca
- Contact Person Email
- atmaca.akin@khnw.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Franziska Modemann
- Principal Investigator Email
- f.modemann@uke.de
- Contact Person Name
- Franziska Modemann
- Contact Person Email
- f.modemann@uke.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- III. Med. Klinik
- Principal Investigator Name
- Jürgen Alt
- Principal Investigator Email
- juergen.alt@unimedizin-mainz.de
- Contact Person Name
- Jürgen Alt
- Contact Person Email
- juergen.alt@unimedizin-mainz.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 18-01-2024
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 673
- Number Of Sites
- 3
- Number Of Participants
- 34
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- “B” Belgyógyászat-Onkológiai és Klinikai Farmakológiai Osztály
- Principal Investigator Name
- Tünde NAGY
- Principal Investigator Email
- drnt@freemail.hu
- Contact Person Name
- Tünde NAGY
- Contact Person Email
- drnt@freemail.hu
- Site Name
- Semmelweis University
- Department Name
- Belgyógyászati és Onkológiai Klinika (Klinikai Farmakológiai Részleg
- Principal Investigator Name
- István TAKÁCS
- Principal Investigator Email
- takacs.istvan@med.semmelweis-univ.hu
- Contact Person Name
- István TAKÁCS
- Contact Person Email
- takacs.istvan@med.semmelweis-univ.hu
- Site Name
- Clinexpert Kft.
- Department Name
- Fázis 1 Vizsgálóhely
- Principal Investigator Name
- Dániel DEME
- Principal Investigator Email
- danieldeme_md@ymail.com
- Contact Person Name
- Dániel DEME
- Contact Person Email
- danieldeme_md@ymail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 18-01-2024
- Latest Decision Or Authorization Date
- 18-11-2025
- Processing Time Days
- 670
- Number Of Sites
- 3
- Number Of Participants
- 31
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Department Name
- NA/ND
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rramlau@medpolonia.com.pl
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rramlau@medpolonia.com.pl
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddział Onkologii i pododdziałem chemioterapii
- Principal Investigator Name
- Jarosław Kołb-Sielecki
- Principal Investigator Email
- j.kolbsielecki@gmail.com
- Contact Person Name
- Jarosław Kołb-Sielecki
- Contact Person Email
- j.kolbsielecki@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Ośrodek Badań Klinicznych Wczesnych Faz
- Principal Investigator Name
- Rafał Dziadziuszko
- Principal Investigator Email
- rafald@gumed.edu.pl
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 18-01-2024
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 805
- Number Of Sites
- 8
- Number Of Participants
- 64
Sites
- Site Name
- MD Anderson Cancer Center
- Department Name
- Oncology
- Principal Investigator Name
- Fernando Fabio Franco Pérez
- Principal Investigator Email
- ffranco@fundacionmdanderson.es
- Contact Person Name
- Fernando Fabio Franco Pérez
- Contact Person Email
- ffranco@fundacionmdanderson.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Principal Investigator Name
- David Vicente Baz
- Principal Investigator Email
- david.vicente.sspa@juntadeandalucia.es
- Contact Person Name
- David Vicente Baz
- Contact Person Email
- david.vicente.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Oscar Jose Juan Vidal
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Oscar Jose Juan Vidal
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Ramon Yarza Barrio
- Principal Investigator Email
- ramon.yarza@startmadrid.com
- Contact Person Name
- Ramon Yarza Barrio
- Contact Person Email
- ramon.yarza@startmadrid.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Victor Moreno García
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno García
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Principal Investigator Name
- Vanesa Varela Pose
- Principal Investigator Email
- vanesa.varela.pose@sergas.es
- Contact Person Name
- Vanesa Varela Pose
- Contact Person Email
- vanesa.varela.pose@sergas.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncology
- Principal Investigator Name
- Enric Carcereny Costa
- Principal Investigator Email
- ecarcereny@iconcologia.net
- Contact Person Name
- Enric Carcereny Costa
- Contact Person Email
- ecarcereny@iconcologia.net
Sponsor
Primary sponsor
- Full Name
- BioNTech SE
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BNT116
- Combination Treatment
- Yes
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