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NCT06171178 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP1012 in Adults With Solid Tumors
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT06171178: Clinical Trial Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT06171178 is a Phase 1 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06171178, a Phase 1 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers. ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. It also makes the cancer cells visible to the immune system which will fight the cancer cells. Before ASP1012 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This will help find a suitable dose for future studies and check for potential medical problems from the treatment. In this study, ASP1012 is being tested in humans for the first time. ASP1012 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed. People in this study will be adults whose tumor has either grown outside of the area where it started (locally advanced) or it has spread to other parts of the body (metastatic). They will receive ASP1012. Also, some people will receive ASP1012 with pembrolizumab, an approved medicine. There are 2 main aims of this study. The first is to learn if people with certain solid tumors can tolerate different doses of ASP1012. The second is to find a suitable dose of ASP1012. This study will be in 3 parts. Part 1 is called Dose Escalation. People with locally advanced or metastatic tumors can take part. They will have been previously treated with all available standard cancer therapies. Different small groups of people will receive lower to higher doses of ASP1012. For each dose, any medical problems will be recorded. This will help to find suitable doses of ASP1012 to use in Parts 2 and 3 of the study. The first group will receive the lowest dose of ASP1012. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP1012. The panel will do this for each group until all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3. Part 2 is called Dose Expansion. 3
Primary Outcome
A DLT will be defined as any event meeting the DLT criteria occurring during the DLT assessment period that is considered possibly, probably or definitely related to ASP1012.
Interventions
- DRUG Pembrolizumab
- DRUG ASP1012
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2025-09-11 |
| Phase | Phase 1 |
Why NCT06171178 stopped before completion
NCT06171178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06171178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06171178 about?
NCT06171178 is a clinical study titled "A Study of ASP1012 in Adults With Solid Tumors". ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers. ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. It also makes the cancer cells visible to the immune system which will fight the cancer cells. Before ASP1012 ...
What is the current status of trial NCT06171178?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-05-15. Estimated completion is 2025-09-11.
What interventions are being tested in trial NCT06171178?
The interventions under investigation include: Pembrolizumab (DRUG), ASP1012 (DRUG).
Who is sponsoring clinical trial NCT06171178?
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 NCT06171178's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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