A Study of ASP1951 in Subjects With Advanced Solid Tumors
Summary
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 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.
Timeline
- Start
- 2019-01-14
- Primary completion
- 2023-07-06
- Completion
- 2023-07-06
Outcome
Outcome not reported
Stopped: “Study was terminated for lack of efficacy.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASP1951 | Unknown | 0.07 mg | Intravenous |
| Subject | ASP1951 | Unknown | 0.7 mg | Intravenous |
| Subject | ASP1951 | Unknown | 5 mg | Intravenous |
| Subject | ASP1951 | Unknown | 20 mg | Intravenous |
| Subject | ASP1951 | Unknown | 70 mg | Intravenous |
| Subject | ASP1951 | Unknown | 200 mg | Intravenous |
| Subject | ASP1951 | Unknown | 700 mg | Intravenous |
| Subject | ASP1951 | Unknown | 1400 mg | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |