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RECRUITING
NCT04740424
PHASE1

FS222 First in Human Study in Patients With Advanced Malignancies

Sponsor: invoX Pharma Limited

View on ClinicalTrials.gov

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

Interventions

DRUG

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