Description:
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.
Title
- Brief Title: IFx-Hu2.0 for the Treatment of Patients With Skin Cancer
- Official Title: Phase 1 Trial of IFx-Hu2.0 to Evaluate Safety in Patients With Skin Cancer
Clinical Trial IDs
- ORG STUDY ID:
SC 2020-01
- NCT ID:
NCT04925713
Conditions
- Cutaneous Squamous Cell Carcinoma
- Basal Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
IFx-Hu2.0 | pAc/emm55 | IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
IFx-Hu2.0 (plasmid DNA) 0.1 mg/lesion | Experimental | 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. | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of Adverse Events |
Time Frame: | 28 days post injection |
Safety Issue: | |
Description: | Rate of Adverse Events reported per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
Secondary Outcome Measures
Measure: | Rate of Pathological Complete Response (pCR) |
Time Frame: | Definitive surgery 4 weeks post treatment |
Safety Issue: | |
Description: | Rate of patients with complete absence of residual viable tumor in the treated tumor bed on histological assessment of fully excised lesion |
Measure: | Rate of Major Pathological Response (mPR) |
Time Frame: | Definitive surgery 4 weeks post treatment |
Safety Issue: | |
Description: | Rate of patients with ≤10% of residual viable tumor present in the treated tumor bed on histological assessment of fully excised lesion |
Measure: | Rate of Partial Pathological Response (pPR) |
Time Frame: | Definitive surgery 4 weeks post treatment |
Safety Issue: | |
Description: | Rate of patients with ≤50% of residual viable tumor present in the treated tumor bed on histological assessment of fully excised lesion |
Measure: | Rate of Pathological Non-Response (pNR) |
Time Frame: | Definitive surgery 4 weeks post treatment |
Safety Issue: | |
Description: | Rate of patients with >50% of residual viable tumor present in the treated tumor bed on histological assessment of fully excised lesion |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Morphogenesis, Inc. |
Trial Keywords
- cSCC
- BCC
- pAc/emm55
- IFx-Hu2.0
- Gene Therapy
- Immunotherapy
- Oncology
- Immunology
- plasmid DNA
Last Updated
July 13, 2021