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 : May 6, 2021
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 Type :||Expanded Access|
|Expanded Access Type :||Individual Patients, Treatment IND/Protocol|
|Official Title:||IFx-Hu2.0 Expanded Access Program|
- 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.
- 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.
Other Name: pAc/emm55
- 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.
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
|Contact: Michael JP Lawman, PhD||813-875-6600 ext email@example.com|
|Contact: Patricia D Lawman, PhD||813-875-6600 ext firstname.lastname@example.org|