Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04853602
Status:
AVAILABLE
Last Update Posted:
2024-08-12
First Post:
2021-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IFx-Hu2.0 Expanded Access Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True, 'individual': True}, 'nPtrsToThisExpAccNctId': 4}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-04-16', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['CM', 'MCC', 'cSCC', 'pDNA', 'plasmid DNA', 'pAc/emm55', 'IFx-Hu.20', 'Immunotherapy', 'Gene Therapy', 'Immunology', 'Oncology', 'Immuno-Oncology'], 'conditions': ['Cutaneous Melanoma, Stage III', 'Cutaneous Melanoma, Stage IV', 'Merkel Cell Carcinoma', 'Cutaneous Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '32556443', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTo request access, use Responsible Party contact information provided in this record..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To request more information use Responsible Party contact information provided in this record\n\nExclusion Criteria:\n\n* To request more information use Responsible Party contact information provided in this record'}, 'identificationModule': {'nctId': 'NCT04853602', 'briefTitle': 'IFx-Hu2.0 Expanded Access Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'TuHURA Biosciences, Inc.'}, 'officialTitle': 'IFx-Hu2.0 Expanded Access Program', 'orgStudyIdInfo': {'id': 'IFx-Hu2.0 Expanded Access'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IFx-Hu2.0', 'type': 'BIOLOGICAL', 'otherNames': ['pAc/emm55'], '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.\n\nTherapeutic Classification:\n\n* Immunomodulatory Agent\n\nRoute of Administration:\n\n* Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions)\n\nMechanism of Action:\n\n* Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells.\n\nPhysiological Effect:\n\n* 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.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'James A Bianco, MD', 'role': 'CONTACT', 'email': 'jbianco@tuhurabio.com', 'phone': '813-875-6600', 'phoneExt': '104'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TuHURA Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}