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IFx-Hu2.0 Expanded Access Program

Primary Purpose

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

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
IFx-Hu2.0
Sponsored by
Morphogenesis, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Cutaneous Melanoma, Stage III focused on measuring CM, MCC, cSCC, pDNA, plasmid DNA, pAc/emm55, IFx-Hu.20, Immunotherapy, Gene Therapy, Immunology, Oncology, Immuno-Oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 16, 2021
    Last Updated
    August 15, 2023
    Sponsor
    Morphogenesis, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04853602
    Brief Title
    IFx-Hu2.0 Expanded Access Program
    Official Title
    IFx-Hu2.0 Expanded Access Program
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Morphogenesis, Inc.

    4. Oversight

    5. Study Description

    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..

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    IFx-Hu2.0
    Other Intervention Name(s)
    pAc/emm55
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    James A Bianco, MD
    Phone
    813-875-6600
    Ext
    104
    Email
    jbianco@morphogenesis-inc.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32556443
    Citation
    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.
    Results Reference
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    IFx-Hu2.0 Expanded Access Program

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