IFx-Hu2.0 Expanded Access Program

NCT04853602 | Unknown

• 1 other identifier: IFx-Hu2.0 Expanded Access
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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..

Conditions

Cutaneous Melanoma, Stage III; Cutaneous Melanoma, Stage IV; Merkel Cell Carcinoma; Cutaneous Squamous Cell Carcinoma

Keywords

CM; MCC; cSCC; pDNA; plasmid DNA; pAc/emm55; IFx-Hu.20; Immunotherapy; Gene Therapy; Immunology; Oncology; Immuno-Oncology

Interventions

IFx-Hu2.0 BIOLOGICAL

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.

Also known as: pAc/emm55

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To request more information use Responsible Party contact information provided in this record

You may not qualify if:

• To request more information use Responsible Party contact information provided in this record

Sponsors & Collaborators

• TuHURA Biosciences, Inc.: lead

Related 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.

  PMID: 32556443 BACKGROUND

MeSH Terms

Conditions

Melanoma; Carcinoma, Merkel Cell; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Central Study Contacts

James A Bianco, MD

CONTACT

813-875-6600; jbianco@tuhurabio.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Last Updated: August 12, 2024

Record last verified: 2024-08