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NCT04837196 · ClinicalTrials.gov registry record · Phase 1
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen
A Phase 1 study of Advanced Cancer and Advanced Malignancies, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 4
- Study locations
NCT04837196: Completed Phase 1 study of Advanced Cancer and Advanced Malignancies, sponsored by Astellas Pharma Global Development.
NCT04837196 is a Phase 1 study of Advanced Cancer and Advanced Malignancies that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 24 participants, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04837196, a Phase 1 study of Advanced Cancer and Advanced Malignancies, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study was to evaluate the safety, tolerability, and clinical response of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of ASP7517 when administered as a single agent and in combination with pembrolizumab. This study also evaluated other measures of anticancer activity of ASP7517 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.
Primary Outcome
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the study drug. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: resulted in death; was life-thre
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG ASP7517
Study Locations (4)
Georgia
- Emory University - Atlanta
Illinois
- University of Chicago - Chicago
Iowa
- University of Iowa Hospitals - Iowa City
Pennsylvania
- UPCI Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-11-11 |
| Est. Completion | 2024-06-21 |
| Phase | Phase 1 |
What the finished NCT04837196 record still lists
NCT04837196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Advanced Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04837196 reports a single indexed study location in Georgia, Illinois, Iowa.
Frequently Asked Questions
What is clinical trial NCT04837196 about?
NCT04837196 is a clinical study titled "Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen". The purpose of this study was to evaluate the safety, tolerability, and clinical response of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of ASP7517 when administered as a single agent and in combination with pembrolizumab. This study also evalu...
What is the current status of trial NCT04837196?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-11-11. Estimated completion is 2024-06-21.
What conditions does trial NCT04837196 study?
This clinical trial studies the following conditions: Advanced Cancer, Advanced Malignancies.
What interventions are being tested in trial NCT04837196?
The interventions under investigation include: Pembrolizumab (DRUG), ASP7517 (DRUG).
Who is sponsoring clinical trial NCT04837196?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04837196 being conducted?
This trial has 4 study locations across Georgia, Illinois, Iowa, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04837196's enrollment target sits among peer trials
24 108th of 122 higher than 14 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer 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.
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