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IFx-Hu2.0 for the Treatment of Patients With Skin Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04925713
Recruitment Status : Completed
First Posted : June 14, 2021
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Morphogenesis, Inc.

Study Description
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Brief Summary:
One hundred patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion. These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-5 days) for any delayed adverse events..

Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma Basal Cell Carcinoma Biological: IFx-Hu2.0 Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

This is a multi-site, open-label, interventional, prospective, phase 1 trial to assess safety and tolerability of IFx-Hu2.0 in patients with basal cell carcinoma, squamous cell carcinoma, or cutaneous melanoma.

A total of approximately one hundred (100) male and/or female adult patients (greater than or equal to 18 years old), of any ethnicity and race, with at least one cutaneous melanoma, squamous cell carcinoma, or basal cell carcinoma lesion accessible for direct injection, who meet all inclusion and no exclusion criteria, will be eligible for enrollment and treatment with IFx-Hu2.0.

Enrollees will receive IFx-Hu2.0 as a single intralesional injection at a single time point. The target dose will be 100 μg of plasmid DNA per lesion injected at a final dose volume of 200 μL per lesion. The injected lesion will be completely excised at the follow-up visit four weeks later and will be biopsied for confirmation of diagnosis and for the establishment of a pathological response baseline peripheral blood will be collected from these patients prior to treatment administration and at the follow-up visit four weeks later. These samples will be used to perform complete blood counts (CBC) and clinical chemistry tests. A urine sample will be obtained for urinalysis for protein and blood at the same frequency. Blood samples will be drawn for immune response evaluation as well.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of IFx-Hu2.0 to Evaluate Safety in Patients With Skin Cancer
Actual Study Start Date : June 10, 2021
Actual Primary Completion Date : October 7, 2021
Actual Study Completion Date : March 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion
One hundred (100) patients will receive 0.1 mg of IFx-Hu2.0 injected intratumorally in a single lesion at a single time point and be followed-up 28 days thereafter.
 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 lymph 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.
Other Name: pAc/emm55


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Adverse Events [ Time Frame: 28 days post injection ]
    Rate of Adverse Events reported per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2. Number of Patients who completed the trial [ Time Frame: 28 days post injection ]
    Number of Patients who completed the trial per protocol without major deviations


Secondary Outcome Measures :
  1. Rate of Pathological Complete Response (pCR) [ Time Frame: Definitive surgery 4 weeks post treatment ]
    Rate of patients with complete absence of residual viable tumor in the treated tumor bed on histological assessment of fully excised lesion

  2. Rate of Major Pathological Response (mPR) [ Time Frame: Definitive surgery 4 weeks post treatment ]
    Rate of patients with ≤10% of residual viable tumor present in the treated tumor bed on histological assessment of fully excised lesion

  3. Rate of Partial Pathological Response (pPR) [ Time Frame: Definitive surgery 4 weeks post treatment ]
    Rate of patients with ≤50% of residual viable tumor present in the treated tumor bed on histological assessment of fully excised lesion

  4. Rate of Pathological Non-Response (pNR) [ Time Frame: Definitive surgery 4 weeks post treatment ]
    Rate of patients with >50% of residual viable tumor present in the treated tumor bed on histological assessment of fully excised lesion


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Ability to receive intralesional injections
  4. Male or female, aged ≥ 18 years
  5. Histologically confirmed cutaneous squamous cell carcinoma, or basal cell carcinoma with accessible lesions (based on archival tissue or new tissue biopsy for histological confirmation)
  6. Life expectancy of at least 24 weeks at the time of screening
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  8. Must have measurable disease greater than 3 mm
  9. At least one injectable lesion

  10. Adequate organ function as defined below (Note: these screening laboratory tests must be obtained within two weeks prior to the baseline visit, Day 0):

    10.1. Hemoglobin (Hb) >10 g/dL 10.2. Absolute Neutrophil Count (ANC) >1,500 cells/mcL 10.3. Platelet Count (PLT) >75,000/mcL 10.4. Prothrombin Time (PT) or International Normalized Ratio (INR) ≤1.5 times the institutional ULN unless patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of the intended use of anticoagulants.

    10.5. Activated Partial Thromboplastin Time (aPTT) ≤1.5 times the institutional ULN unless patient is receiving anticoagulant therapy as long as aPTT is within therapeutic range of the intended use of anticoagulants.

    10.6. Serum Creatinine (SCr) ≤1.5 times the institutional ULN 10.7. Total Bilirubin ≤1.5 times the institutional ULN 10.8. Aspartate Aminotransferase (AST) ≤3 times the institutional ULN 10.9. Alanine Aminotransferase (ALT) ≤3 times the institutional ULN 10.10. Lactate Dehydrogenase (LDH) ≤2 times the institutional ULN 10.11. Alkaline Phosphatase (ALP) ≤2.5 times the institutional ULN 10.12. Gamma GT (GGT) ≤2.5 times the institutional ULN

  11. Lymphocyte count ≥500,000 cells/mL
  12. For females of reproductive potential: must have a negative urine or serum pregnancy test result within 24 hours prior to receiving IFx-Hu2.0; must use highly effective contraception (e.g.,licensed hormonal or barrier methods) for at least one month prior to screening and agreement to use such a method during study participation and for an additional 26 weeks after the end of study treatment
  13. For males of reproductive potential: use of barrier method or other methods to ensure effective contraception with partner

Exclusion Criteria:

  1. Concurrent participation in any other clinical trial
  2. Inability to consent for self
  3. Lesions on scalp with bone erosions must not be selected as injection sites for IFx-Hu2.0
  4. Life expectancy of fewer than 24 weeks at the time of screening
  5. Prior systemic anti-cancer treatment within three weeks from start of treatment (Day 0)
  6. Treatment with any investigational product within the three weeks preceding injection
  7. Concurrent chemotherapy or biological therapy. Concurrent radiotherapy is allowed as long as it is not the same site as the injected lesion.
  8. Current treatment with systemic immunosuppressive corticosteroid (greater than 10 mg of daily prednisone) doses or other immunosuppressants such as those needed for solid organ transplants. Medications needed to treat conditions such as reactive airway disease are not excluded.
  9. Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 26 weeks after the last dose of trial treatment
  10. Immunizations for encapsulated bacteria were not given for patients who have undergone a splenectomy
  11. Serious underlying medical or psychiatric conditions, active infections requiring the use of antimicrobial drugs, or active bleeding that would make the subject unsuitable or unable to participate in the study
  12. Active Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) or Hepatitis B/C. Patients with treated HIV/AIDS or Hepatitis B/C with no evidence of active infection may be enrolled
  13. History of organ allograft transplantation
  14. Presence of any uncontrolled and significant medical or psychiatric condition which would interfere with trial safety assessments
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04925713


Locations
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United States, Florida
Moore Clinical Research
Brandon, Florida, United States, 33716
Sponsors and Collaborators
Morphogenesis, Inc.
More Information
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Responsible Party: Morphogenesis, Inc.
ClinicalTrials.gov Identifier: NCT04925713    
Other Study ID Numbers: SC 2020-01
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Morphogenesis, Inc.:
cSCC
BCC
pAc/emm55
IFx-Hu2.0
Gene Therapy
 Immunotherapy
Oncology
Immunology
plasmid DNA
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases