To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

Inclusion Criteria:

1. Subject has provided written informed consent prior to initiation of study-specifiedprocedures.

2. Subject is 18 years of age or older.

3. Eastern Cooperative Oncology Group performance status 0, 1 or 2.

4. Subject has a single lesion that is histologically confirmed as BCC. The externallyvisible component of the lesions should be at least 1 cm in one dimension tofacilitate accurate and reproducible measurement, to 5 cm at longest diameter, thatin the opinion of the investigator: A. is considered not a good candidate for surgery or has recurred after definitivesurgical treatment and curative surgical resection is unlikely. OR B. subject has a medical contraindication to surgery where acceptable medicalcontraindications to surgery include:

• Anticipated substantial morbidity and/or deformity from surgery (e.g., removalof all or part of a vital facial structure, such as nose, ear, eyelid, eye; orrequirement for limb amputation).

• Medical conditions predisposing to poor surgical outcome (e.g., diabetes withhistory of poor wound healing).

• Other conditions considered to be medically contraindicating must be discussedwith the Medical Monitor before enrolling the subject. A copy of the surgical consultation note must be provided. laBCC with prior historyof or ongoing HPPI treatment are eligible under the following conditions:

• Achieved objective response with disease progression >3 months after treatmentdiscontinuation.

• Achieve best response of PR with persistent disease that continues to meetstudy inclusion criteria and has been off treatment for at least 3 months. Note: where the subject has >1 lesion, one lesion may be selected for treatment atthe discretion of the investigator.

5. Radiotherapy is contraindicated or inappropriate in the opinion of the investigator,for example, hypersensitivity to radiation due to genetic syndrome such as Gorlinsyndrome, limitations because of location of tumor, or anticipated significantmorbidity, loss of function, or unacceptable cosmetic outcomes. Patients with BasalCell Nevus Syndrome (Gorlin syndrome) may enroll in this study but must meet thecriteria for locally advanced or listed above.

6. Subject is able and willing to comply with all study requirements including biopsiesat baseline and during the study. Biopsy 3-4 mm preferred, biopsies must be <25% ofthe area the tumor. Screening biopsies performed 1-12 weeks before Day 1.

7. Subject has adequate hematopoietic capacity, as defined by the following:

• Neutrophil count >1,500/mm3

• Hemoglobin >9 g/dL

• Platelet count >100,000/ mm3

• Prothrombin international normalized ratio <1.5

8. Subject has adequate hepatic function, as defined by the following:

• Total bilirubin <1.5 × the upper limit of normal (ULN) or within 3 × the ULNfor patients with Gilbert disease

• Aspartate aminotransferase, alanine aminotransferase or alkaline phosphate <2 ×the ULN

9. Adequate renal function, as defined by the following:

• Creatinine <1.5 x ULN

10. For female subjects of childbearing potential*, agreement to use two acceptablemethods of contraception (including one barrier method), during the study and for atleast (per United States Prescribing Information [USPI]) 24 months afterdiscontinuation of vismodegib. For male subjects with female partners of childbearing potential*, agreement to usea latex condom, and to advise their female partner to use an additional method ofcontraception during the study and for at least (per USPI) 24 months afterdiscontinuation of vismodegib.

11. Subjects agree not to donate blood or blood products during the study and for atleast (per USPI) 24 months after discontinuation of vismodegib; male subjects agreenot to donate sperm during the study and for at least 2 months after discontinuationof vismodegib.

• Childbearing potential is defined as any female who has experienced menarcheand who has not undergone surgical sterilization (hysterectomy or bilateraloophorectomy) and is not postmenopausal. Menopause is defined as 12 months ofamenorrhea in the absence of other biological causes. In addition, femalesunder the age of 55 years must have a documented serum follicle stimulatinghormone level >40 mIU/mL to confirm menopause.

Exclusion Criteria:

1. laBCC that has progressed on systemic HHPI therapy as defined below:

• Best response of progressive disease (primary progression).

• Objective response followed by disease progression while on HHPI treatment.

• laBCC with a best response of stable disease on systemic HHPI treatment.

2. laBCC that has recurred in the same location after two or more surgical procedures,or that has recurred following radiation therapy.

3. laBCC that has bone involvement (radiologically confirmed if clinically suspected).

4. laBCC with invasion of underlying soft tissue that is not accessible by standardsyringe/needle.

5. Patients with evidence of metastatic BCC.

6. Female subjects who are lactating or pregnant.

7. Life expectancy of <12 weeks.

8. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, othertargeted therapy, or radiation therapy).

9. Recent (within 4 weeks of Day 1), current, or planned participation in anexperimental drug study.

10. History of other malignancies within 3 years of Day 1, except for tumors with anegligible risk for metastasis or death, such as adequately treated basal andsquamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, orcarcinoma in situ of the cervix.

11. Uncontrolled medical illnesses such as infection requiring treatment withintravenous antibiotics.

12. History of other stable disease, metabolic dysfunction, physical examinationfinding, or clinical laboratory finding giving reasonable suspicion of a disease orcondition that contraindicates use of an investigational drug or that might affectinterpretation of the results of the study or renders the subject at high risk fromtreatment complications.