drugset / Trial / NCT04160065
Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers
Phase 1
Completed
23 enrolled
TuHURA Biosciences, Inc.
Dana-Farber Cancer Institute · collabH. Lee Moffitt Cancer Center and Research Institute · collabHuntsman Cancer Institute · collabUniversity of Southern California · collab
NaSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2020-03-03
- Primary completion
- 2023-10-19
- Completion
- 2024-08-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IFx-Hu2.0 | Vaccine | 0.1 mg | Other |