Metastatic Colorectal Cancer Clinical Trial
Official title:
A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With Metastatic Colorectal Cancer
The purpose of this study is to test the safety and efficacy of an experimental drug,
OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized
bispecific monoclonal antibody and was developed to target cancer stem cells. Based on
preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells
and may also impair the productive growth of new blood vessels, which tumors need to grow and
spread.
The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the
Sponsor.
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus FOLFIRI or FOLFOX to evaluate the safety, efficacy, and pharmacokinetics of OMP-305B83 in combination with FOLFIRI or FOLFOX in patients with metastatic Colorectal Cancer. This study consists of a screening period, a treatment period, and a post-treatment follow-up period in which patients will be followed for survival for up to 5 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. ;
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