A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies

Inclusion Criteria:

1. Signed written informed consent

2. ≥18 years of age

3. Histologically or cytologically confirmed solid tumor that is metastatic or
unresectable and for which standard curative or palliative measures do not exist or
are no longer effective

4. Measurable disease as per RECIST v1.1 criteria

5. Adequate hematologic status as demonstrated by not requiring transfusion support or
granulocyte-colony stimulating factor (G-CSF) to maintain: ANC ≥1500 cells/mm3,
Platelet count ≥100 x 109/L, Hemoglobin ≥10 g/dL

6. Adequate liver function as demonstrated by:Total bilirubin of ≤1.5 mg/dL or ≤2.0 mg/dL
for subjects with liver metastasis, Alanine aminotransferase ≤3 x upper limit of
normal (ULN) or ≤5 x ULN if liver metastasis is present, Alkaline phosphatase ≤3 x ULN
or ≤5 x ULN if bone or liver metastasis is present

7. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN or creatinine
clearance calculation ≥60 mL/min as calculated by the Cockcroft and Gault formula

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

9. Life expectancy of at least 3 months

10. Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by
hysterectomy and/or bilateral oophorectomy) or must be using effective contraception
(ie, oral contraceptives, intrauterine device, double barrier method of condom and
spermicide) and agree to continue use of contraception for 30 days after their last
dose of study drug.

11. Sexually active male subjects must use a barrier method of contraception during the
study and agree to continue the use of male contraception for at least 30 days after
the last dose of study drug.

Exclusion Criteria:

1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or
previous investigational products (IPs)

2. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever
is longer

3. Are currently receiving other medications or radiation intended for the treatment of
their malignancy

4. Women of childbearing potential who are pregnant or breastfeeding

5. Currently taking a concomitant medication

6. Require therapeutic use of anticoagulation medications

7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, myocardial infarction within the last
6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease
requiring oxygen, known bleeding disorders, or any concomitant illness or social
situation that would limit compliance with study requirements

8. Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI
disease or other medical condition that, in the opinion of the investigator may
interfere with oral drug absorption

9. History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity type
reaction to Cremophor