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.
ClinicalTrials.gov Identifier: NCT03655756 (completed)
In this clinical phase I, non-randomized, open-label, uncontrolled, interventional, multi-center trial, 20 adult subjects (≥ 18 years of age) with advanced Merkel cell carcinoma (MCC) or cutaneous squamous cell carcinoma (cSCC) 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).
ClinicalTrials.gov Identifier: NCT04160065 (recruiting)
This is an open-label, multi-site, non-controlled, interventional, randomized phase 2 trial of IFx-Hu2.0 ± PD-1 antagonist for the treatment of patients with stage III to IV cutaneous melanoma who are primarily (i.e. no response) or secondarily (i.e. progression) refractory to at least 1 cycle (i.e. 12 weeks) of an FDA-approved PD-1 antagonist therapy per the respective, current label.
Currently under IRB Review.