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FS222 First in Human Study in Patients With Advanced Malignancies
Sponsor: invoX Pharma Limited
Summary
This study will be conducted in adult participants diagnosed with advanced tumours to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS222. This is a Phase 1, multi-center, open label, multiple-dose, first in human study, designed to systematically assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS222 in participants with advanced tumours. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
Official title: A Phase 1, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects With Advanced Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2020-12-14
Completion Date
2027-10-30
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
FS222
Dosing of participants will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Locations (21)
Calvary Mater Newcastle
Waratah, New South Wales, Australia
One Clinical Research Perth
Perth, Western Australia, Australia
Arensia Exploratory Medicine, LLC
Tbilisi, Georgia
SLK Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, Germany
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, Netherlands
Centrum Medyczne Poznan - PRATIA - PPDS
Poznan, Greater Poland Voivodeship, Poland
MCM Krakow - PRATIA - PPDS
Krakow, Poland
Prof. Dr. Alexandru Trestioreanu Oncologic Institute
Bucharest, Romania
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca, Romania
Clinica Universidad Navarra
Pamplona, Navarre, Spain
NEXT - Hospital Quironsalud Barcelona
Barcelona, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Institut Catala d'Oncologia de Badalona
Barcelona, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Spain
Instituto de Investigación Sanitaria Fundación Jimenez Díaz
Madrid, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
NEXT - Hospital Universitario Quironsalud Madrid
Madrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Spain
Universitary Hospital Virgen Macarena
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain