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NCT05646797 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP2074 in Adults With Solid Tumors
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT05646797: Clinical Trial Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT05646797 is a Phase 1 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05646797, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
ASP2074 is a potential new treatment for people with certain solid tumors. Before ASP2074 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose and check for potential medical problems from the treatment. People in this study will be adults with metastatic or locally advanced solid tumors. Metastatic means the cancer has spread to other parts of the body. They will have been previously treated with all available standard therapies and they may no longer be benefitting from further treatment. There are 2 main aims of this study. The first is to learn if people with certain solid tumors have any medical problems after receiving different doses of ASP2074. The second is to find a suitable dose of ASP2074 to use in future studies. This study will be in 2 parts. In Part 1, different small groups of people will receive lower or higher doses of ASP2074. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP2074 to use in Part 2 of the study. The first group will receive the lowest dose of ASP2074. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP2074. The panel will do this for each group until all groups have taken ASP2074 or until suitable doses have been selected for Part 2. In Part 2, other different small groups of people will receive ASP2074 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP2074 to use in future studies. ASP2074 will be given as an infusion on the first day of each treatment cycle. The people in this study will have treatment cycles until: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment. People will visit the clinic on certain days during their treatment, w
Primary Outcome
A Dose Limiting Toxicity (DLT) is defined as any prespecified Adverse events (AEs) or laboratory findings occurring during the DLT evaluation period excluding toxicities clearly related to disease progression or intercurrent illness.
Interventions
- DRUG ASP2074
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-02-28 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 1 |
Why NCT05646797 stopped before completion
NCT05646797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which ASP2074 is the first listed.
NCT05646797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05646797 about?
NCT05646797 is a clinical study titled "A Study of ASP2074 in Adults With Solid Tumors". ASP2074 is a potential new treatment for people with certain solid tumors. Before ASP2074 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose and check for potential medical problems from the t...
What is the current status of trial NCT05646797?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2023-02-28. Estimated completion is 2024-10-17.
What interventions are being tested in trial NCT05646797?
The interventions under investigation include: ASP2074 (DRUG).
Who is sponsoring clinical trial NCT05646797?
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 NCT05646797's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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