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NCT05346484 · ClinicalTrials.gov registry record · Phase 1
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
A Phase 1 study, sponsored by Imugene Limited.
- Terminated
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT05346484: Clinical Trial Phase 1 study, sponsored by Imugene Limited.
NCT05346484 is a Phase 1 study that was terminated before completion, run by Imugene Limited. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05346484, a Phase 1 study, was terminated before completion, sponsored by Imugene Limited.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab or mFOLFOX in patients with metastatic or advanced solid tumors.
Primary Outcome
Adverse events will be graded according to CTCAE v5.0.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL CF33-hNIS
- DRUG Modified FOLFOX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2022-05-17 |
| Est. Completion | 2026-01-12 |
| Phase | Phase 1 |
Why NCT05346484 stopped before completion
NCT05346484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05346484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05346484 about?
NCT05346484 is a clinical study titled "A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors". This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab or mFOLFOX i...
What is the current status of trial NCT05346484?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2022-05-17. Estimated completion is 2026-01-12.
What interventions are being tested in trial NCT05346484?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), CF33-hNIS (BIOLOGICAL), Modified FOLFOX (DRUG).
Who is sponsoring clinical trial NCT05346484?
This trial is sponsored by Imugene Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05346484's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 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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