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NCT03655756 · ClinicalTrials.gov registry record · Early Phase 1
pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma
A Early Phase 1 study, sponsored by TuHURA Biosciences.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
NCT03655756: Completed Early Phase 1 study, sponsored by TuHURA Biosciences.
NCT03655756 is a Early Phase 1 study that has completed, run by TuHURA Biosciences. The registered enrollment target is 7 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03655756, a Early Phase 1 study, has completed, sponsored by TuHURA Biosciences.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Six patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion, two lesions, or three lesions, as a monotherapy (a maximum of three lesions could be injected). These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-7 business days for any delayed adverse events.
Primary Outcome
Safety was reported using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Feasibility was defined as the ability to treat at least five of the six patients enrolled without drug-related dose-limiting toxicity (DLT).
Interventions
- BIOLOGICAL IFx-Hu2.0
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2020-11-30 |
| Phase | Early Phase 1 |
What the finished NCT03655756 record still lists
NCT03655756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which IFx-Hu2.0 is the first listed.
NCT03655756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03655756 about?
NCT03655756 is a clinical study titled "pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma". Six patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion, two lesions, or three lesions, as a monotherapy (a maximum of three lesions could be injected). These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-7 business...
What is the current status of trial NCT03655756?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2018-11-05. Estimated completion is 2020-11-30.
What interventions are being tested in trial NCT03655756?
The interventions under investigation include: IFx-Hu2.0 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03655756?
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 NCT03655756's enrollment target sits among peer trials
7 1825th of 2000 higher than 156 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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