A Phase II Study of TRC105 in Patients With Hepatocellular Carcinoma (HCC) Who Have Progressed on Sorafenib
Background:
- Worldwide, hepatocellular carcinoma (HCC) is the fifth most common malignancy with a
median survival of 6-9 months. The SHARP study established Sorafenib as a standard
consideration in this disease and set the bar for future studies of systemic therapy.
There is no standard therapy for patients whose disease has progressed despite
Sorafenib therapy.
- TRC105 is a chimeric, anti-angiogenic monoclonal antibody that binds CD105, a
transmembrane receptor overexpressed by proliferating endothelial cells. TRC105 binds
to CD105-expressing endothelial cells and mediates growth inhibition, apoptosis and
antibody-dependent cell-mediated cytotoxicity (ADCC).
Objectives:
Primary:
-To evaluate time to tumor progression (TTP) for TRC105 in HCC.
Secondary:
- To evaluate safety of TRC105 in HCC.
- To evaluate the immunogenicity of TRC105 as measured by human antichimeric antibody
(HACA) and human antimouse antibody formation.
- To evaluate anti-tumor response as determined by standard and EASL-modified RECIST
response criteria.
- To perform correlative studies assessing potential biomarkers of response to TRC105.
Eligibility:
- Histologically or cytologically confirmed diagnosis of HCC.
- Childs-Pugh A or B (7 points) cirrhosis only is allowed.
- Patients must have disease that is not amenable to potentially curative resection.
- Patients must have progressed on or been intolerant of prior sorafenib therapy.
- No history of bleeding varices (unless subsequent liver transplant). All patients must
have had endoscopic evaluation within 6 months of starting study.
- No history of bleeding varices in previous 1 year (unless subsequent liver transplant).
No anti-coagulation (except low-dose aspirin).
Design:
- This is a single-arm phase II study of TRC105 in patients with HCC.
- TRC105 will be administered as an intravenous infusion every two weeks. Patients will
be re-staged every 8 weeks.
- The primary endpoint of the study will be Time to Tumor Progression (TTP). The primary
purpose of this study is to evaluate the ability of TRC105 as a second line treatment
to improve upon the time to progression (TTP) of patients with refractory HCC.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate time to tumor progression (TTP) for TRC105 in HCC.
2 years
No
Tim F Greten, M.D.
Principal Investigator
National Cancer Institute (NCI)
United States: Federal Government
110181
NCT01375569
June 2011
June 2013
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |