Study of Topical SOR007 Ointment for Cutaneous Metastases

This is a Phase 1/2, open-label, dose-rising study evaluating the safety, tolerability and
preliminary efficacy of three concentrations of SOR007 (Uncoated Nanoparticle Paclitaxel)
Ointment (0.15%, 1.0%, and 2.0%) applied to non-melanoma cutaneous metastases. A treatment
area of 50 cm2 will be selected by the Investigator. Using a gloved hand, subjects will apply
one Finger Tip Unit (FTU) of SOR007 to the 50 cm2 treatment area twice daily at approximately
the same time each day for 28 days. At each visit (Days 1, 8, 15, 29, and 43), at least two
global and two close-up color photographs of the treatment area will be taken (with a ruler
for scale). The photographs will be analyzed with ImageJ. Eligible lesions will be determined
at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter).
The study will include a dose escalation phase and a dose expansion phase.

In the dose escalation phase, formal safety reviews will be conducted after the last subject
in each cohort of three subjects completes 15 days of treatment. The next dose level will
enroll upon a finding of safety and tolerability. The top dose or the maximum tolerated dose
(if DLT occurs) will be taken into the dose expansion phase and additional subjects will be
enrolled to reach a maximum of 12 subjects at that dose.

Inclusion Criteria:

1. Signed informed consent;

2. Male and female patients ≥ 18 years of age;

3. Malignancies resulting in cutaneous metastasis originating from: breast, lung, head
and neck, pancreatic, urinary bladder, prostate, testicular, ovarian, uterine,
cervical, gastric, adrenal, thyroid, parathyroid cancers, or other solid tumors which
previously responded to taxane treatment;

4. Cutaneous metastases diagnosis confirmed prior to consent by preferred institutional
methodology which may include, but is not limited to: biopsy ≤ 3 months; conventional
radiography; imaging techniques to include bone scan (scintigraphy), computed
tomography (CT), fluorodeoxyglucose-positron emission tomography (FDG-PET)/CT),
magnetic resonance imaging (MRI), F-fluoromisonidazole-(F-FMISO) PET/CT,
fluorothymidine-(FLT) PET/CT, fluoroestradiol-(FES) PET/CT, and PET/MRI;

5. ECOG Grade 0 - 2, with minimum life expectancy of at least 3 months;

6. At least one baseline eligible lesion. Per RECIST criteria (version 1.1), an eligible
lesion at baseline is considered measurable when ≥ 10mm diameter in the longest
diameter;

7. Willing to refrain from using other lotions, creams, etc. during the treatment period;

8. Subjects with adequate organ and bone marrow function as defined below:

- ANC ≥ 1,500/µl

- Hemoglobin ≥ 9.5 grams/dL

- Platelets ≥ 75,000/µl

- AST (aspartate transaminase or SGOT)/ALT (alanine aminotransferase or SGPT) ≤ 3.0
x ULN and total bilirubin ≤ 2.0 x ULN with no evidence of cholestasis

- Creatinine ≤ 1.5x ULN;

9. Last dose of any systemic non-taxane cytotoxic chemotherapy completed at least one day
prior to Day 1. Last dose of any systemic taxane cytotoxic chemotherapy completed at
least 4 weeks prior to Day 1

10. Willing to use appropriate birth control for patients of child-bearing potential;

11. Abstinence from all manner of physical contact near the treatment area during and up
to 2 weeks after the treatment phase.

Exclusion Criteria:

1. Open or ulcerated wound(s) extending through the dermis within the treatment area;

2. Colorectal, hepatocellular, gallbladder, cholangiocarcinoma, neuroendocrine,
melanomas, hematological and central nervous system (CNS) malignancies;

3. Active viral hepatitis A, B, or C or preexisting or acute liver disease;

4. Treatment with the following within the 4 weeks prior to the screening visit:
radiotherapy, intralesional therapy; laser therapy surgery (other than biopsy) to the
target area, local hyperthermia, levulinic acid, 5-fluorouracil, high potency
corticosteroids (including systemic steroids), retinoids, diclofenac, hyaluronic acid,
imiquimod;

5. Elective surgery for treatment of the cutaneous metastases during the study and up to
4 weeks after the treatment period. Cutaneous metastases are required to remain
in-situ and measurable for up to 2 weeks after last treatment to achieve study
objectives;

6. Known allergic reactions, irritations or sensitivity to the active ingredients or
other components of SOR007;

7. Symptoms of a clinically significant illness that may place the subject at risk by
trial participation or influence the outcome of the trial in the four weeks before
first treatment and during the trial;

8. Participation in the treatment phase of another clinical trial within the four weeks
prior to treatment in this clinical trial;

9. Investigator's opinion of subject's probable noncompliance or inability to understand
the trial and/or give adequate informed consent;

10. Evidence of current chronic alcohol or drug abuse;

11. Pregnancy and/or lactating.