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NCT03954067 · ClinicalTrials.gov registry record · Phase 1
A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT03954067 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 72 participants.
The verdict
NCT03954067, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study 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.
Interventions
- COMBINATION_PRODUCT Pembrolizumab
- BIOLOGICAL ASP9801
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2019-09-03 |
| Est. Completion | 2024-04-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03954067
The ClinicalTrials.gov registry entry for NCT03954067 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03954067 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03954067 about?
NCT03954067 is a clinical study titled "A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors". 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 wi...
What is the current status of trial NCT03954067?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2019-09-03. Estimated completion is 2024-04-19.
What interventions are being tested in trial NCT03954067?
The interventions under investigation include: Pembrolizumab (COMBINATION_PRODUCT), ASP9801 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03954067?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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