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
|
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
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 |
See clinical trials of the intervention/treatment in this expanded access record. | |
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.
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.
Other Name: pAc/emm55

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

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: James A Bianco, MD | 813-875-6600 ext 104 | jbianco@morphogenesis-inc.com |
Publications:
Responsible Party: | Morphogenesis, Inc. |
ClinicalTrials.gov Identifier: | NCT04853602 |
Other Study ID Numbers: |
IFx-Hu2.0 Expanded Access |
First Posted: | April 21, 2021 Key Record Dates |
Last Update Posted: | July 13, 2021 |
Last Verified: | July 2021 |
CM MCC cSCC pDNA plasmid DNA pAc/emm55 |
IFx-Hu.20 Immunotherapy Gene Therapy Immunology Oncology Immuno-Oncology |
Carcinoma, Merkel Cell Carcinoma Melanoma Skin Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue |
Nevi and Melanomas Neoplasms by Site Skin Diseases Polyomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Carcinoma, Neuroendocrine Adenocarcinoma |