An Open Label Phase 1B Dose-Escalation Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that
inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor
types. TRC105, a monoclonal antibody to CD105, is a novel angiogenesis inhibitor that
complements bevacizumab in preclinical models. Together, these antibodies may result in
more effective angiogenesis inhibition and improved clinical efficacy over that seen with
bevacizumab alone. The purpose of the study is to evaluate safety and tolerability and
determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in
patients with advanced solid tumors for which bevacizumab is indicated.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine Maximum Tolerated Dose of TRC105 in Combination with Bevacizumab
Safety and dose limiting toxicity will be assessed by dose cohort.
Bryan R Leigh, MD
Tracon Pharmaceuticals Inc.
United States: Food and Drug Administration
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Premiere Oncology||Santa Monica, California 90404|
|Indiana University Simon Cancer Center||Indianapolis, Indiana 46202|
|Pinnacle Oncology Hematology||Scottsdale, Arizona 85258|