Main

Inclusion Criteria:

1. Signed written informed consent granted prior to initiation of any study-specific
procedures;

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

3. ERBB2 (HER-2) gene amplification or ERBB2 overexpression

4. Histologically or cytologically confirmed cancer, either locally advanced or
metastatic;

5. No anti-tumor therapy of proven benefit available at study enrollment;

6. Life expectancy of >=3 months;

7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;

8. Male or female patients of child-producing potential must agree to use contraceptive
measures or oral contraception during the study and for 28 days after the last dose
of TrasGEX™;

9. Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days prior to the first dose of TrasGEX™;

and

Main Exclusion Criteria:

1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
within 4 weeks of the first dose of TrasGEX™;

2. Major surgery within four weeks of the first dose of TrasGEX™;

3. Newly diagnosed brain metastases, metastases that have been documented to be stable
for <3 months, or metastases for which systemic corticosteroids are required;

4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition as TrasGEX™;

5. History of myocardial infarction within 12 months of the administration of the first
dose of TrasGEX™;

6. History of congestive heart failure defined as Class II to IV per New York Heart
Association classification within 12 months of the administration of the first dose
of TrasGEX™;

7. Left ventricular ejection fraction <50%;

8. Previous malignancy other than the current diagnosis within 5 years of the first dose
of TrasGEX™;

9. Pregnancy or lactation; and

10. Concurrent uncontrolled significant illness