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Spots Global Cancer Trial Database for FS222 First in Human Study in Patients With Advanced Malignancies

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Trial Identification

Brief Title: FS222 First in Human Study in Patients With Advanced Malignancies

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

Study ID: NCT04740424

Interventions

FS222

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Arensia Exploratory Medicine, LLC, Tbilisi, , Georgia

Prof. Dr. Alexandru Trestioreanu Oncologic Institute, Bucharest, , Romania

"Dr. Carol Davila" Nephrology Clinical Hospital, Bucharest, , Romania

Prof Dr I Chiricuta Institute of Oncology, Cluj-Napoca, , Romania

Clinica Universidad Navarra, Pamplona, Navarra, 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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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