[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428020":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":15,"locations":7,"responsibleParty":22,"collaborators":7,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":28,"acronym":7,"eligibilityCriteria":29,"healthyVolunteers":26,"sex":30,"minAge":31,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":32,"phases":7,"briefSummary":33,"conditions":34,"keywords":39,"overallStatus":51,"whyStopped":7,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":56,"locationsCount":7},{"fullName":5,"class":6},"TuHURA Biosciences, Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"BIOLOGICAL","IFx-Hu2.0","The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc\u002Femm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA\u002Fpolyethylenimine 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.",[14],"pAc\u002Femm55",[16],{"name":17,"role":18,"phone":19,"phoneExt":20,"email":21},"James A Bianco, MD","CONTACT","813-875-6600","104","jbianco@tuhurabio.com",{"type":23,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100428020","ifx-hu20-expanded-access-program-100428020",false,"NCT04853602","IFx-Hu2.0 Expanded Access Program","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","ALL","18 Years","EXPANDED_ACCESS","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..",[35,36,37,38],"Cutaneous Melanoma, Stage III","Cutaneous Melanoma, Stage IV","Merkel Cell Carcinoma","Cutaneous Squamous Cell Carcinoma",[40,41,42,43,44,14,45,46,47,48,49,50],"CM","MCC","cSCC","pDNA","plasmid DNA","IFx-Hu.20","Immunotherapy","Gene Therapy","Immunology","Oncology","Immuno-Oncology","AVAILABLE","2024-08-08",{"date":54,"type":55},"2024-08-12","ACTUAL",{"name":5,"class":6}]