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NCT04853602 Clinical Trial

IFx-Hu2.0 Expanded Access Program

Merkel Cell Carcinoma Clinical Trial

Official title:
IFx-Hu2.0 Expanded Access Program

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT04853602
Other study ID # IFx-Hu2.0 Expanded Access
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date February 2024
Source TuHURA Biosciences, Inc.
Contact James A Bianco, MD
Phone 813-875-6600
Email jbianco@tuhurabio.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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..

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• IFx-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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
TuHURA Biosciences, Inc.

References & Publications (1)

Bunch BL, Kodumudi KN, Scott E, Morse J, Weber AM, Berglund AE, Pilon-Thomas S, Markowitz J. Anti-tumor efficacy of plasmid encoding emm55 in a murine melanoma model. Cancer Immunol Immunother. 2020 Dec;69(12):2465-2476. doi: 10.1007/s00262-020-02634-4. Epub 2020 Jun 18. — View Citation

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