TrasGEX™: Phase 1 Study in Cancer Patients

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