This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Dosing of participants with FS120 or the combination pembrolizumab will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) or once every 3 weeks (Q3W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.
Yale University
New Haven, Connecticut, United States
MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Huntsman Cancer Institute, University of Utah
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)
Safety and tolerability will be evaluated by collection of AEs, SAEs and DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Time frame: 24 months
Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Time frame: 24 months
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Salt Lake City, Utah, United States
NEXT Oncology, Hospital Quironsalud Barcelona
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain