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IFx-Hu2.0 Expanded Access Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04853602
Expanded Access Status : Available
First Posted : April 21, 2021
Last Update Posted : July 13, 2021
Information provided by (Responsible Party):
Morphogenesis, Inc.

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.

Condition or disease Intervention/treatment
Cutaneous Melanoma, Stage III Cutaneous Melanoma, Stage IV Merkel Cell Carcinoma Cutaneous Squamous Cell Carcinoma Biological: IFx-Hu2.0

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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: IFx-Hu2.0 Expanded Access Program

Intervention Details:
  • 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.
    Other Name: pAc/emm55

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04853602

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Contact: James A Bianco, MD 813-875-6600 ext 104

Sponsors and Collaborators
Morphogenesis, Inc.
Additional Information:
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Responsible Party: Morphogenesis, Inc. Identifier: NCT04853602    
Other Study ID Numbers: IFx-Hu2.0 Expanded Access
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Keywords provided by Morphogenesis, Inc.:
plasmid DNA
Gene Therapy
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine