A Phase 1 Trial of Intralesional Immunotherapy with IFx-Hu2.0 Vaccine in Patients with Advanced Non Melanoma
Trial Description: 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).
- Conditions: cutaneous squamous cell carcinoma, merkel cell carcinoma, non-melanoma skin cancers
- Phase: I
- Trial ID: NCT04160065
- Protocol ID: 19-871