Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)

Inclusion Criteria:

1. Subjects must have a histological diagnosis of cSCC based upon a skin biopsy.

2. Subjects must have resectable stage I-III disease.

• Measures ≥5 millimeters (mm; post-biopsy) and <100 mm in longest diameter

3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

4. Subjects must have an expected survival of greater than or equal to 12 months.

5. Subjects must not be on any other investigational device/drug treatment.

6. Subjects must be willing to adhere to the instructions of the Investigator and hisresearch team and sign an Informed Consent Form prior to entry into the study.

7. Subjects must have the following pretreatment laboratory parameters: granulocytes ≥1,500/mm3; platelets >50,000/mm3; serum creatinine ≤2X the upper limit of normal (ULN); AST, ALT ≤3X the ULN, bilirubin ≤1.5X ULN unless Gilbert's disease then ≤3XULN.

8. Subjects must be at least 18 years of age and must be able to understand the writteninformed consent/assent document.

9. Subjects must have no evidence of active infection, regardless of the degree ofseverity or localization. Subjects with active infections (whether or not theyrequire antibiotic therapy) may be eligible for study participation after completeresolution of the infection. Subjects on antibiotic therapy must be off antibioticsbefore beginning treatment.

10. Subjects must not receive any other treatment for cSCC except emollients ofsubject's choice without topical steroids, anti-fungal or antibacterial topicalpreparations.

11. Subjects with multiple cSCC may re-enroll in the study if greater than 4 weekselapses between courses and if all other inclusion/exclusion criteria are met.

12. Patients with HIV infection with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL will beeligible for the study. Patients without a history of AIDS-defining opportunisticinfections will be eligible for the study.

13. Subjects must be willing/able to comply with standard of care measures for subjectswith cSCC such as sun avoidance and sun protection.

Exclusion Criteria:

1. Subjects with the following tumor characteristics:

• >4 mm depth;

• Clark level IV;

• perineural invasion, lymphovascular invasion;

• primary site on the ear or non-glabrous lip;

• location in the hands or feet;

• large size: ≥10 mm on neck or pretibial area; ≥20 mm on trunk or extremities;

• indistinct borders;

• rapid growth;

• recurrent lesion;

• lesion in site of chronic inflammation or prior radiation therapy;

• presence of neurologic symptoms; or • poorly differentiated, and aggressivehistopathologic subtypes.

2. Subjects with uncontrolled pain that would preclude participation in the study.

3. Subjects who are pregnant or lactating.

4. Subjects who have sensitivity to drugs that provide local anesthesia.

5. Impaired cardiac function or clinically significant cardiac disease, including anyof the following:

• Symptomatic congestive heart failure requiring treatment

• Clinically significant cardiac arrhythmia

• Uncontrolled hypertension

• Corrected QT interval (QTc) >470 msec at Screening or congenital long QTsyndrome

• Acute myocardial infarction or unstable angina pectoris < 3 months prior to thefirst dose

• New York Heart Association Functional Class III or higher (i.e. markedlimitation of physical activity due to symptoms, or unable to carry on anyphysical activity without discomfort)

6. Subjects with other active malignancies with the exception of non-metastaticprostate cancer and carcinoma in situ of the skin and cervix.

7. Active, known, or suspected autoimmune disease or a documented history of autoimmunedisease, except vitiligo or resolved childhood asthma/atopy.

• Individuals with vitiligo, type I diabetes, residual hypothyroidism only requiringhormone replacement, psoriasis not requiring systemic treatment, history ofHashimoto's thyroiditis on stable dose of thyroid hormone replacement therapy,adrenal insufficiency only requiring physiologic steroid replacement, or conditionsnot expected to recur should not be excluded.

8. Major surgery within 2 weeks of the first dose of study agent

9. History of or current drug-induced interstitial lung disease or pneumonitis Grade ≥2

10. Subjects with the disease only on the face, skin folds, head, scalp, and genitalarea.