A Phase 1, Open-Label, Dose-Escalation, and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, in Patients With Advanced Malignancies That Have Progressed On or After Prior PD-1/PD-L1 Containing Therapy

What is the purpose of this trial?

This study will be conducted in adult patients diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. 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 FS118 in patients with advanced tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.



F-star Delta Limited

Start Date: 08/15/2018

End Date: 12/16/2019

Last Updated: 02/11/2019

Study HIC#: 2000022786

Get Involved

For more information about this study, contact:
Stephanie Rosini
+1 203-785-2963
stephanie.vetter@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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Investigators

Patricia LoRusso

Principal Investigator

Sub-Investigators