Hepatocellular Carcinoma Clinical Trial
Official title:
An Open Label Phase 1B/2 Trial of TRC105 and Sorafenib in Patients With Hepatocellular Carcinoma (HCC)
The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a
recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with
hepatocellular carcinoma. Up to 18 patients will be treated.
The purpose of the phase 2 portion is to estimate the ORR of patients with hepatocellular
carcinoma by RECIST 1.1. Up to 21 patients will be treated in phase 2.
Sorafenib is an oral multikinase inhibitor targeting several receptor tyrosine kinases, including the VEGF receptor (VEGFR), implicated in pathologic angiogenesis, tumor growth, and cancer progression. Sorafenib is approved for the treatment of unresectable hepatocellular carcinoma (HCC). TRC105 is an antibody to endoglin, an important angiogenic target on proliferating endothelial cells that is distinct from VEGFR. TRC105 inhibits angiogenesis, tumor growth and metastases and complements the activity of bevacizumab and multi-kinase inhibitors that target the VEGFR in preclinical models. Together, the use of TRC105 with sorafenib may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with sorafenib alone. ;
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