Clinical trial • Phase I/II • Oncology
pembrolizumab for Advanced solid tumors
Phase I/II trial of pembrolizumab for Advanced solid tumors. 79 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I/II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 30-07-2025
- First CTIS Authorization Date
- 19-11-2025
Trial design
Phase I/II trial across 11 sites in France, Spain, Poland.
- Target Sample Size
- 79
Recruitment
- Planned Sample Size
- 79
- Recruitment Window Months
- 46
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 21
France
- Earliest CTIS Part Ii Submission Date
- 06-11-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 162
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncologist
- Contact Person Name
- Caroline EVEN
- Contact Person Email
- Caroline.even@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Contact Person Name
- Jérôme FAYETTE
- Contact Person Email
- jerome.fayette@lyon.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Véronique DEBIEN
- Contact Person Email
- v.debien@bordeaux.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Medical Oncology
- Contact Person Name
- Amaury DASTE
- Contact Person Email
- amaury.daste@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Centre d’Essais Précoces en Cancérologie de Marseille (CEPCM)
- Contact Person Name
- Sébastien SALAS
- Contact Person Email
- sebastien.salas@ap-hm.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 31-10-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 171
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology department
- Contact Person Name
- Irene Braña García
- Contact Person Email
- ibrana@vhio.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology department
- Contact Person Name
- Pablo Gajate Borau
- Contact Person Email
- pablo.gajate@salud.madrid.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology department
- Contact Person Name
- Manuel Pedregal Trujillo
- Contact Person Email
- manuel.pedregal@startmadrid.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology department
- Contact Person Name
- Desamparados Roda Pérez
- Contact Person Email
- droda@incliva.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology department
- Contact Person Name
- Javier Torres Jimenez
- Contact Person Email
- javiertorresjimenez92@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 169
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oddział w Gliwicach; Centrum Wsparcia Badań Klinicznych
- Contact Person Name
- Tomasz Rutkowski
- Contact Person Email
- tomasz.rutkowski@gliwice.nio.gov.pl
Sponsor
Primary sponsor
- Full Name
- Pyxis Oncology Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- PYX-201
- Investigational Product Name
- Pembrolizumab
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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