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NCT06257758 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors
A Phase 1 study, sponsored by Valerio Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT06257758: Clinical Trial Phase 1 study, sponsored by Valerio Therapeutics.
NCT06257758 is a Phase 1 study that was terminated before completion, run by Valerio Therapeutics. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06257758, a Phase 1 study, was terminated before completion, sponsored by Valerio Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this phase 1/2 clinical trial is to investigate the safety of an investigational drug called VIO-01 when taken by people who have different types of solid tumor cancers. There are two parts to this trial, part 1 and part 2. Part 1 of the trial aims to answer these questions: * The safety and tolerability of VIO-01 when it is given alone or in combination with other anti-cancer therapies. * The highest dose that people can take without having unacceptable side effects * How well your body tolerates the drug alone or in combination, how they are absorbed, and the effects they have on your disease. Part 2 of the trial will further test VIO-01's effect in participants with advanced HRRm or HRD+ solid tumors and HRRm/HRD+ recurrent ovarian cancer. Participants will follow a schedule of visits to the study site to have assessments done related to their health condition and to receive the trial treatment.
Primary Outcome
As measured by adverse events observed
Interventions
- DRUG VIO-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2024-01-10 |
| Est. Completion | 2025-01-01 |
| Phase | Phase 1 |
Why NCT06257758 stopped before completion
NCT06257758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which VIO-01 is the first listed.
NCT06257758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06257758 about?
NCT06257758 is a clinical study titled "A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors". The goal of this phase 1/2 clinical trial is to investigate the safety of an investigational drug called VIO-01 when taken by people who have different types of solid tumor cancers. There are two parts to this trial, part 1 and part 2. Part 1 of the trial aims to answer these questions: * The safe...
What is the current status of trial NCT06257758?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2024-01-10. Estimated completion is 2025-01-01.
What interventions are being tested in trial NCT06257758?
The interventions under investigation include: VIO-01 (DRUG).
Who is sponsoring clinical trial NCT06257758?
This trial is sponsored by Valerio Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06257758's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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