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.|
|ClinicalTrials.gov Identifier: NCT04853602|
Expanded Access Status : Available
First Posted : April 21, 2021
Last Update Posted : July 13, 2021
|First Submitted Date||April 16, 2021|
|First Posted Date||April 21, 2021|
|Last Update Posted Date||July 13, 2021|
|Brief Title||IFx-Hu2.0 Expanded Access Program|
|Official Title||IFx-Hu2.0 Expanded Access Program|
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.
|Detailed Description||Not Provided|
|Study Type||Expanded Access|
|Expanded Access Type||Individual Patients, Treatment IND/Protocol|
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.
Route of Administration:
Mechanism of Action:
Other Name: pAc/emm55
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Available|
|Ages||18 Years and older (Adult, Older Adult)|
|Listed Location Countries||Not Provided|
|Removed Location Countries|
|Other Study ID Numbers||IFx-Hu2.0 Expanded Access|
|Responsible Party||Morphogenesis, Inc.|
|Study Sponsor||Morphogenesis, Inc.|
|PRS Account||Morphogenesis, Inc.|
|Verification Date||July 2021|