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NCT04160065 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers
A Phase 1 study, sponsored by TuHURA Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT04160065: Completed Phase 1 study, sponsored by TuHURA Biosciences.
NCT04160065 is a Phase 1 study that has completed, run by TuHURA Biosciences. 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
NCT04160065, a Phase 1 study, has completed, sponsored by TuHURA Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
In this clinical phase I, non-randomized, open-label, uncontrolled, interventional, multi-center trial, 20 adult subjects (≥ 18 years of age) with advanced non-melanoma skin cancers will receive a fixed dose of 0.1 mg of IFx-Hu2.0 intralesionally as monotherapy in up to three lesions at up to three time points. Subjects will be observed for any acute adverse events (AEs) post injection and for any delayed AEs at Day 28, 35 and/or 42 ± 7 days, depending on the cohort (exposure escalation and expansion design).
Interventions
- BIOLOGICAL IFx-Hu2.0
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-03-03 |
| Est. Completion | 2024-08-13 |
| Phase | Phase 1 |
What the finished NCT04160065 record still lists
NCT04160065 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 IFx-Hu2.0 is the first listed.
NCT04160065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04160065 about?
NCT04160065 is a clinical study titled "Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers". In this clinical phase I, non-randomized, open-label, uncontrolled, interventional, multi-center trial, 20 adult subjects (≥ 18 years of age) with advanced non-melanoma skin cancers will receive a fixed dose of 0.1 mg of IFx-Hu2.0 intralesionally as monotherapy in up to three lesions at up to three ...
What is the current status of trial NCT04160065?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-03-03. Estimated completion is 2024-08-13.
What interventions are being tested in trial NCT04160065?
The interventions under investigation include: IFx-Hu2.0 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04160065?
This trial is sponsored by TuHURA Biosciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04160065'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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