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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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