Phase II/III Trial of Cetuximab Plus Irinotecan Synchronously/Subsequently in Patients With KRAS Wild-type Metastatic Colorectal Cancer: an Randomized, Open-label, Multicenter, Prospective Study
CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds
specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a
murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is
expressed by Chinese hamster ovary cells. It is a biosimilar of cetuximab (C225, Erbitux®)
and it is developed by NERCAM and produced by Biomabs. Phase I study results suggest that
CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter,
open-label study was to determine whether adding cetuximab (CMAB009) to irinotecan increased
the response rate and prolongs survival in patients with KRAS wild-type metastatic
colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Tumor response was evaluated every 6 weeks and confirmed at least 4 weeks later
Time to progression, assessed up to two years
Yes
S Y Kai
Principal Investigator
Cancer Hospital, Chinese Academy of Medical Sciences
China: Food and Drug Administration
CMAB009mCRCⅡ/Ⅲ
NCT01550055
March 2009
December 2012
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