Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma
Conditions
Keywords
CM, MCC, cSCC, pDNA, plasmid DNA, pAc/emm55, IFx-Hu.20, Immunotherapy, Gene Therapy, Immunology, Oncology, Immuno-Oncology
Brief summary
Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options. To request access, use Responsible Party contact information provided in this record..
Interventions
BIOLOGICALIFx-Hu2.0
The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer. Therapeutic Classification: * Immunomodulatory Agent Route of Administration: * Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions) Mechanism of Action: * Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells. Physiological Effect: * Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses. In addition to priming anti-tumor immunity in immune checkpoint inhibitor (ICI)-naïve patients, this could re-sensitize patients with primary or secondary ICI clinical resistance.
Sponsors
TuHURA Biosciences, Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* To request more information use Responsible Party contact information provided in this record
Exclusion criteria
* To request more information use Responsible Party contact information provided in this record
Contacts
Primary ContactJames A Bianco, MD
Outcome results
None listed