A Phase I Study of the Safety and Pharmacokinetics of a Fully Human Monoclonal Antibody to the Vascular Endothelial Growth Factor Receptor2 (Tanibirumab) in Patients With Advanced Cancers or Metastatic Cancer
This is a Phase I, first-in-human, open-label, non-randomized, dose-escalating study of
Tanibirumab which is a fully human monoclonal antibody to vascular endothelial growth factor
receptor 2 (VEGFR2/KDR). This study will enroll patients with advanced or metastatic cancer
who are refractory or for whom there are no standard therapeutic options. Tanibirumab will
be administered intravenously to such patients over 60 minutes on Day 1, 8, and 15 (subject
to change pending PK and toxicity data). Each treatment cycle will be a minimum of 28 days
in length. The dose escalation study employing a 3 + 3 design is designed to identify the
RP2D which will be based on safety, tolerability and PK of the RP2D. This study is expected
to enroll a total of approximately 18-24 patients.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
The safety and tolerability of Tanibirumab will be assessed using the following measures: frequency and nature of dose-limiting toxicities (DLTs); nature, severity, and relatedness of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v4.0; changes in vital signs; and changes in clinical laboratory parameters.
Young Seok Park, MD, PhD
Samsung Medical Center
Korea: Food and Drug Administration