Clinical trial • Phase I • Oncology

FS222 for Advanced malignancies | Advanced cancer

Phase I trial of FS222 for Advanced malignancies | Advanced cancer. None/Not specified-controlled. 38 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced malignancies | Advanced cancer
Trial Stage
Phase I
Drug Modality
Other antibody

Key dates

Initial CTIS Submission Date
29-05-2024
First CTIS Authorization Date
17-06-2024

Trial design

None/Not specified-controlled Phase I trial across 25 sites in Spain, Poland, Romania and others.

Comparator
None/Not specified
Target Sample Size
38

Recruitment

Planned Sample Size
38
Recruitment Window Months
78

Geography

Total Number Of Sites
25
Total Number Of Participants
323

Spain

Earliest CTIS Part Ii Submission Date
12-06-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
628
Number Of Sites
12
Number Of Participants
234

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology Department
Contact Person Name
Guillermo Antonio de Velasco Oria de Rueda
Contact Person Email
gdevelasco.gdv@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Medical Oncology Department
Contact Person Name
Victor Moreno Garcia
Contact Person Email
victor.moreno@startmadrid.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Medical Oncology Department
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology Department
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net
Site Name
Hospital Quironsalud Barcelona
Department Name
Medical Oncology Department
Contact Person Name
Guzman Alonso Casal
Contact Person Email
galonso@nextoncology.eu
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology Department
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Medical Oncology Department
Contact Person Name
Teresa Garcia Manrique
Contact Person Email
tgarciamanrique.onco@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Medical Oncology Department
Contact Person Name
Ignacio Melero Bermejo
Contact Person Email
imelero@unav.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Medical Oncology Department
Contact Person Name
Mariano Provencio Pulla
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology Department
Contact Person Name
Maria Ochoa de Olza Amat
Contact Person Email
maochoa@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology Department
Contact Person Name
Ivan Manuel Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology Department
Contact Person Name
Andres Cervantes Ruiperez
Contact Person Email
andres.cervantes@uv.es

Poland

Earliest CTIS Part Ii Submission Date
04-03-2025
Latest Decision Or Authorization Date
06-04-2025
Processing Time Days
359
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Pratia S.A.
Contact Person Name
Anna Drosik-Kwaśniewska
Contact Person Email
adrosik-kwasniewska@pratia.pl
Site Name
Biokinetica S.A.
Contact Person Name
Rafał Stec
Contact Person Email
drrafals@wp.pl
Site Name
Pratia Hematologia Sp. z o.o.
Contact Person Name
Agata Kachel-Flis
Contact Person Email
agata.kachel-flis@pratia.com
Site Name
Pratia S.A.
Contact Person Name
Marek Kotlarski
Contact Person Email
marek.kotlarski@pratia.com

Romania

Earliest CTIS Part Ii Submission Date
12-06-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
628
Number Of Sites
2
Number Of Participants
35

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Phase 1 Unit, Radiotherapy
Contact Person Name
Tudor Eliade Ciuleanu
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Phase 1 Unit, Medical Oncology II, Radiotherapy I
Contact Person Name
Nicoleta Laurentia Gales

Netherlands

Earliest CTIS Part Ii Submission Date
27-03-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
337
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Medische Oncologie
Contact Person Name
Frank Speetjens
Contact Person Email
f.m.speetjens@lumc.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medische Oncologie
Contact Person Name
Carla van Herpen
Contact Person Email
carla.vanherpen@radboudumc.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medische Oncologie
Contact Person Name
Tim Schutte
Contact Person Email
fase1@nki.nl

Germany

Earliest CTIS Part Ii Submission Date
14-03-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
349
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Dirk Schadendorf
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Klinikum am Gesundbrunnen
Contact Person Name
Uwe Martens
Contact Person Email
uwe.martens@slk-kliniken.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Early Clinical Trial Unit (ECTU)
Contact Person Name
Sebastian Ochsenreither
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Fakultät Carl Gustav Carus Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC)
Contact Person Name
Martin Wermke

Sponsor

Primary sponsor

Full Name
Invox Pharma Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Investigational products

Investigational Product Name
FS222
Modality
Other antibody
First In Human
Yes

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