A phase I first-in-human study of TRC105 (Anti-Endoglin Antibody) in patients with advanced cancer.

ABSTRACT:

Purpose

TRC105 is a chimeric IgG1 monoclonal antibody that binds CD105 (endoglin). This first-in-human, phase I, open-label study assessed safety, pharmacokinetics, and antitumor activity of TRC105 in patients with advanced refractory solid tumors.

Patients and methods

Patients received escalating doses of intravenous TRC105 until disease progression or unacceptable toxicity using a standard 3 + 3 phase I design.

Results

Fifty patients were treated with escalating doses of TRC105. The maximum tolerated dose (MTD) was exceeded at 15 mg/kg every week because of dose-limiting hypoproliferative anemia. TRC105 exposure increased with increasing dose, and continuous serum concentrations that saturate CD105 receptors were maintained at 10 mg/kg weekly (the MTD) and 15 mg/kg

SUBMITTER: Rosen LS 

PROVIDER: S-EPMC3432706 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature