Dataset from A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors

The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab.

本研究旨在评估ASP1948单药或联合纳武利尤单抗（nivolumab）或帕博利珠单抗（pembrolizumab）给药时，在局部晚期（不可切除）或转移性实体瘤受试者中的耐受性与安全性特征；明确ASP1948单药及联合上述两种药物给药时的药代动力学特征，并确定其单药及联合给药时的推荐II期剂量（recommended Phase 2 dose, RP2D）；此外本研究还将评估ASP1948单药及联合纳武利尤单抗或帕博利珠单抗给药时的抗肿瘤疗效。