A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced 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 Version 1.1 criteria.

5. Adequate bone marrow reserve as demonstrated by

- Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L

- Platelet count ≥ 100 x 10⁹/L

- Hemoglobin (Hgb) ≥ 9 g/L

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 (ALT)≤ 3 x upper limit of normal (ULN) or ≤ 5x ULN if
liver metastasis is present

- ALP ≤ 3 x ULN or ≤ 5 x ULN if bone metastasis is present

7. Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN, or 24-hr
urine creatinine clearance calculation >60 mL/min

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

9. Life expectancy of at least 3 months

10. Subjects who are not currently taking prohibited medication

11. Women must be postmenopausal (> 12 months without menses) or surgically sterile (ie,
by hysterectomy and/or bilateral oophorectomy) or must be using effective
contraception

Exclusion Criteria:

1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or
previous investigational agents

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

3. Women of childbearing potential who are pregnant or breast feeding.

4. 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 psychiatric illness/social
situations that would limit compliance with study requirements

5. Significant or uncontrolled cardiovascular disease or bleeding disorder

6. 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

7. Subjects with a known history of allergy to paclitaxel. Subjects whose allergy was
due to the IV solvent (such as Cremophor®) and not paclitaxel will be eligible for
this study.