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NCT03565445 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 190
- Enrollment target
NCT03565445 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 190 participants.
The verdict
NCT03565445, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 190 participants
- Enrollment target
Study 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.
Interventions
- DRUG pembrolizumab
- DRUG nivolumab
- DRUG ASP1948
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2018-07-02 |
| Est. Completion | 2023-03-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03565445
The ClinicalTrials.gov registry entry for NCT03565445 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 190 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 3 interventions - of which pembrolizumab is the first listed.
NCT03565445 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03565445 about?
NCT03565445 is a clinical study titled "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". 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 ...
What is the current status of trial NCT03565445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2018-07-02. Estimated completion is 2023-03-27.
What interventions are being tested in trial NCT03565445?
The interventions under investigation include: pembrolizumab (DRUG), nivolumab (DRUG), ASP1948 (DRUG).
Who is sponsoring clinical trial NCT03565445?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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