Clinical Trials

Sponsor: Astellas Pharma US, Inc.

Sponsor Study ID: 1951-CL-0101

Study Title: A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

NCT Number: NCT03799003

Phase: I

Protocol Type: Treatment

Age Group: Adult

Disease Sites: Larynx, Lip, Oral Cavity and Pharynx, Lung, Melanoma, Skin, Thyroid

Study Objectives: The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 when administered as a single agent and in combination with pembrolizumab and/or maximum tolerated dose (MTD). This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.

If you would like to contact a MUSC study team member to learn more information about this study, click HERE.