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NCT05578872 · ClinicalTrials.gov registry record · Phase 1
A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1).
A Phase 1 study, sponsored by Anaveon.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT05578872: Completed Phase 1 study, sponsored by Anaveon.
NCT05578872 is a Phase 1 study that has completed, run by Anaveon. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05578872, a Phase 1 study, has completed, sponsored by Anaveon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. The study has 3 parts. Part 1 to evaluate ANV419 in monotherapy and Parts 2 and 3 to evaluate ANV419 in combination with anti-PD1 antibody or anti-CTLA4 antibody. Parts 2 and 3 were not initiated, as the prespecified efficacy criteria to graduate to Part 2 were not met at the interim analysis of Part 1.
Primary Outcome
Proportion of participants with a complete response (CR) or partial response (PR) to treatment as defined by RECIST v1.1 (ORR = CR + PR)
Interventions
- DRUG ANV419
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2022-12-16 |
| Est. Completion | 2024-08-01 |
| Phase | Phase 1 |
What the finished NCT05578872 record still lists
NCT05578872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which ANV419 is the first listed.
NCT05578872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05578872 about?
NCT05578872 is a clinical study titled "A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1).". The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. The study has 3 parts. Part 1 to evaluate ANV419...
What is the current status of trial NCT05578872?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2022-12-16. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT05578872?
The interventions under investigation include: ANV419 (DRUG).
Who is sponsoring clinical trial NCT05578872?
This trial is sponsored by Anaveon, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05578872's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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