Clinical trial • Phase I • Oncology
pembrolizumab for Advanced solid tumors
Phase I trial of pembrolizumab for Advanced solid tumors. 27 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody|Other
Key dates
- Initial CTIS Submission Date
- 11-07-2025
- First CTIS Authorization Date
- 22-09-2025
Trial design
Phase I trial across 5 sites in Germany, Spain.
- Target Sample Size
- 27
Eligibility
Recruits 27 Vulnerable population not selected for this trial (isVulnerablePopulationSelected: false); no specific consent or assent handling for vulnerable populations is provided in the available documents..
- Vulnerable Population
- Vulnerable population not selected for this trial (isVulnerablePopulationSelected: false); no specific consent or assent handling for vulnerable populations is provided in the available documents.
Recruitment
- Planned Sample Size
- 27
- Recruitment Window Months
- 17
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 27
Germany
- Earliest CTIS Part Ii Submission Date
- 10-09-2025
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik m. S. Haematologie, Onkologie und Tumorimmunologie
- Contact Person Name
- Sebastian Ochsenreither
- Contact Person Email
- sebastian.ochsenreither@charite.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- lnnere Medizin VIII - Medizinische Onkologie und Pneumologie
- Contact Person Name
- Ulrich Lauer
- Contact Person Email
- ulrich.lauer@uni-tuebingen.de
Spain
- Earliest CTIS Part Ii Submission Date
- 24-07-2025
- Latest Decision Or Authorization Date
- 22-09-2025
- Processing Time Days
- 60
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Alberto Hernando Calvo
- Contact Person Email
- albertohernando@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Bernard Doger de Spèville
- Contact Person Email
- Bernard.doger@startmadrid.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Emiliano Calvo Aller
- Contact Person Email
- emiliano.calvo@startmadrid.com
Sponsor
Primary sponsor
- Full Name
- Abalos Therapeutics GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- ABX-001
- Modality
- Other
- Investigational Product Name
- pembrolizumab
- Active Substance
- pembrolizumab
- Modality
- Monoclonal antibody
- Authorisation Status
- Marketed
- Combination Treatment
- Yes
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