TrasGEX™: Phase 1 Study in Cancer Patients

Adult patients with advanced and/or metastatic HER2-positive cancer who were resistant to or for whom there was no standard anti-tumor therapy available at the time of enrollment and who had an estimated life expectancy of at least 3 months were eligible for participation in this study.

Patients were to receive the study drug until disease progression (clinical or radiologic), unacceptable toxicity, or any other reason leading to termination of study treatment.

Dose-escalation was performed in 3 to 6-patient cohorts.

Main Inclusion Criteria:

• Signed written informed consent granted prior to initiation of any study-specific procedures;
• Male or female patients of ≥18 years of age;
• ERBB2 (HER-2) gene amplification or ERBB2 overexpression
• Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
• No anti-tumor therapy of proven benefit available at study enrollment;
• Life expectancy of >=3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;
• 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™;
• 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:

• Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
• Major surgery within four weeks of the first dose of TrasGEX™;
• Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required;
• History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
• History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
• 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™;
• Left ventricular ejection fraction <50%;
• Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
• Pregnancy or lactation; and
• Concurrent uncontrolled significant illness