IFx-Hu2.0 for the Treatment of Patients With Skin Cancer

Status Completed

Clinical Trial Summary

One hundred patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion. These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-5 days) for any delayed adverse events..

Clinical Trial Description

This is a multi-site, open-label, interventional, prospective, phase 1 trial to assess safety and tolerability of IFx-Hu2.0 in patients with basal cell carcinoma, squamous cell carcinoma, or cutaneous melanoma. A total of approximately one hundred (100) male and/or female adult patients (greater than or equal to 18 years old), of any ethnicity and race, with at least one cutaneous melanoma, squamous cell carcinoma, or basal cell carcinoma lesion accessible for direct injection, who meet all inclusion and no exclusion criteria, will be eligible for enrollment and treatment with IFx-Hu2.0. Enrollees will receive IFx-Hu2.0 as a single intralesional injection at a single time point. The target dose will be 100 μg of plasmid DNA per lesion injected at a final dose volume of 200 μL per lesion. The injected lesion will be completely excised at the follow-up visit four weeks later and will be biopsied for confirmation of diagnosis and for the establishment of a pathological response baseline peripheral blood will be collected from these patients prior to treatment administration and at the follow-up visit four weeks later. These samples will be used to perform complete blood counts (CBC) and clinical chemistry tests. A urine sample will be obtained for urinalysis for protein and blood at the same frequency. Blood samples will be drawn for immune response evaluation as well. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04925713
Study type	Interventional
Source	Morphogenesis, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	June 10, 2021
Completion date	March 10, 2022

View Details

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