進行固形癌患者を対象とした、免疫チェックポイント阻害剤ASP8374の単剤およびペムブロリズマブとの併用による多回投与試験
基本情報
- NCT ID
- NCT03260322
- ステータス
- 完了
- 試験のフェーズ
- 第1相
- 試験タイプ
- 介入
- 目標被験者数
- 169
- 治験依頼者名
- Astellas Pharma Inc
概要
The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate \[ORR\], duration of response \[DOR\], persistence of response after discontinuation, and disease control rate \[DCR\]) of ASP8374 when administered as a single agent and in combination with pembrolizumab. NTP: Neutropenia NHAE:Non-haematological AE GBS: Guillain-Barré syndrome"" IRR: Infusion-related reaction AST: Aspartate aminotransferase ALT: Alanine aminotransferase MS/MG: Myasthenia Syndrome/Myasthenia Gravis TRT: Treatment-related Toxicity TCP: Thrombocytopenia