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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 is a Phase 1 study that has completed, run by TuHURA Biosciences. The registered enrollment target is 23 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04160065
The ClinicalTrials.gov registry entry for NCT04160065 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TuHURA Biosciences, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IFx-Hu2.0 is the first listed.
NCT04160065 reports 0 study locations.
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.
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