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
CTO #: 103245
NCT Number: NCT03799003
Phase: I
Protocol Type: Treatment
Age Group: Adults
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.