drugset / Trial / NCT03565445
A 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
Phase 1
Completed
190 enrolled
Astellas Pharma Global Development, Inc.
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2018-07-02
- Primary completion
- 2023-03-27
- Completion
- 2023-03-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASP1948 | Unknown | 70 mg | Intravenous |
| Subject | ASP1948 | Unknown | 200 mg | Intravenous |
| Subject | ASP1948 | Unknown | 700 mg | Intravenous |
| Subject | ASP1948 | Unknown | 1200 mg | Intravenous |
| Subject | ASP1948 | Unknown | 2000 mg | Intravenous |
| Subject | ASP1948 | Unknown | 3000 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |