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NCT03799003 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP1951 in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT03799003: Clinical Trial Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT03799003 is a Phase 1 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03799003, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
A DLT is defined as any of the prespecified Adverse Events (AEs) (graded using National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 4.03) that the investigator (or sponsor) cannot clearly attribute to a cause other than study drug.
Interventions
- DRUG pembrolizumab
- DRUG ASP1951
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2023-07-06 |
| Phase | Phase 1 |
Why NCT03799003 stopped before completion
NCT03799003 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 2 interventions - of which pembrolizumab is the first listed.
NCT03799003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03799003 about?
NCT03799003 is a clinical study titled "A Study of ASP1951 in Subjects With Advanced Solid Tumors". 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 ASP19...
What is the current status of trial NCT03799003?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2019-01-14. Estimated completion is 2023-07-06.
What interventions are being tested in trial NCT03799003?
The interventions under investigation include: pembrolizumab (DRUG), ASP1951 (DRUG).
Who is sponsoring clinical trial NCT03799003?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03799003's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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