Spots Global Cancer Trial Database for A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies
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Trial Identification
Brief Title: A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies
Official Title: A Phase 1/2, Open-Label, Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, as a Monotherapy and in Combination With Paclitaxel, in Patients With Advanced Malignancies
Study ID: NCT03440437
Study Description
Brief Summary: This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS118 in participants with advanced tumors and to determine the efficacy of FS118 in participants with squamous cell carcinoma of the head and neck (SCCHN) as monotherapy and in combination with paclitaxel. In addition to safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy will also be assessed.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Los Angeles (UCLA), Los Angeles, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Emory Healthcare, Atlanta, Georgia, United States
University of Cincinnati, Cincinnati, Ohio, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
CHU Bordeaux, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
Centre Lyon Berard, Lyon, , France
La Timone, Marseille, , France
Centre Antoine Lacassagne, Nice, , France
Contact Details
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