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NCT04939701 · ClinicalTrials.gov registry record · Phase 1
Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04939701: Clinical Trial Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT04939701 is a Phase 1 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04939701, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab. This study also evaluated the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.
Primary Outcome
DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as: * Grade (GR) ≥2 autoimmune reaction * GR 3 Immune related AEs (irAEs) that did not resolve to GR ≤1 in 3 to 5 days, febrile neutropenia with or without infection, thrombocytopenia with bleeding requiring transfusion, anemia requiring transfusion * GR 4 irAEs, neutropenia, thrombocytopenia, anemia * GR ≥3 non-hematological AE that did not resolve to GR ≤2 within 72 hours of onset, liver function test abnor
Interventions
- DRUG ASP0739
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-12-23 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 1 |
Why NCT04939701 stopped before completion
NCT04939701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which ASP0739 is the first listed.
NCT04939701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04939701 about?
NCT04939701 is a clinical study titled "Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants". The purpose of this study was to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab. This study also evaluated the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and ...
What is the current status of trial NCT04939701?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-12-23. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT04939701?
The interventions under investigation include: ASP0739 (DRUG).
Who is sponsoring clinical trial NCT04939701?
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 NCT04939701's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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