drugset / Trial / NCT03954067
A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors
Phase 1
Completed
72 enrolled
Astellas Pharma Global Development, Inc.
Merck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab, an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor.
Timeline
- Start
- 2019-09-03
- Primary completion
- 2024-04-19
- Completion
- 2024-04-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASP9801 | Other / unclassified | 1e+07 unknown | Other |
| Subject | ASP9801 | Other / unclassified | 1e+08 unknown | Other |
| Subject | ASP9801 | Other / unclassified | 5e+08 unknown | Other |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |