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IFx-Hu2.0 Expanded Access Program

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ClinicalTrials.gov Identifier: NCT04853602
Expanded Access Status : Available
First Posted : April 21, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Morphogenesis, Inc.

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Interventions
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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
Eligibility Criteria
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Information from the National Library of Medicine

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

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 and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04853602


Contacts
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Contact: James A Bianco, MD 813-875-6600 ext 104 jbianco@morphogenesis-inc.com

Sponsors and Collaborators
Morphogenesis, Inc.
More Information
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Additional Information:

Publications:

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Responsible Party: Morphogenesis, Inc.
ClinicalTrials.gov 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.:
CM
MCC
cSCC
pDNA
plasmid DNA
pAc/emm55
 IFx-Hu.20
Immunotherapy
Gene Therapy
Immunology
Oncology
Immuno-Oncology
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Melanoma
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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
Infections
Tumor Virus Infections
Carcinoma, Neuroendocrine
Adenocarcinoma