This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEXâ„¢ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEXâ„¢ on the development of anti-drug antibodies and on tumour response was also evaluated.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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™;
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™;
What they're measuring
1
optimal dose and regimen of TrasGEXâ„¢
Timeframe: up to at least 8 weeks after the first TrasGEXâ„¢ administration
✕. 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™;