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
Other|Monoclonal antibody

Key dates

Initial CTIS Submission Date
13-12-2024
First CTIS Authorization Date
28-04-2025

Trial design

Phase I trial across 5 sites in Germany, Spain.

Target Sample Size
27

Recruitment

Planned Sample Size
27
Recruitment Window Months
20

Geography

Total Number Of Sites
5
Total Number Of Participants
27

Germany

Earliest CTIS Part Ii Submission Date
06-04-2025
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
22
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
Principal Investigator Name
Sebastian Ochsenreither
Principal Investigator Email
sebastian.ochsenreither@charite.de
Contact Person Name
Sebastian Ochsenreither
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
lnnere Medizin VIII - Medizinische Onkologie und Pneumologie
Principal Investigator Name
Ulrich Lauer
Principal Investigator Email
ulrich.lauer@uni-tuebingen.de
Contact Person Name
Ulrich Lauer
Contact Person Email
ulrich.lauer@uni-tuebingen.de

Spain

Earliest CTIS Part Ii Submission Date
04-04-2025
Latest Decision Or Authorization Date
28-04-2025
Processing Time Days
24
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Principal Investigator Name
Emiliano Calvo Aller
Principal Investigator Email
emiliano.calvo@startmadrid.com
Contact Person Name
Emiliano Calvo Aller
Contact Person Email
emiliano.calvo@startmadrid.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Bernard Doger de Spèville
Principal Investigator Email
Bernard.doger@startmadrid.com
Contact Person Name
Bernard Doger de Spèville
Contact Person Email
Bernard.doger@startmadrid.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Alberto Hernando Calvo
Principal Investigator Email
albertohernando@vhio.net
Contact Person Name
Alberto Hernando Calvo
Contact Person Email
albertohernando@vhio.net

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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