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
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
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

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

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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