Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer (CRC009)

Shanghai Zhangjiang Biotechnology Limited Company

Status and phase

Completed

Phase 3

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Irinotecan-only and sequential-CMAB009

Drug: CMAB009 plus Irinotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01550055

CMAB009mCRCⅡ/Ⅲ

CMAB009 (Registry Identifier)

Details and patient eligibility

About

The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

Full description

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 has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company 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 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.

Enrollment

512 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically confirmed metastatic colorectal adenocarcinoma
KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
ECOG performance status 0 to 1
Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve

Exclusion criteria

Previous irinotecan or anti-EGFR therapies
hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
Renal function: serum creatinine, more than 1.5 times the upper limit of normal
Patients with symptomatic central nervous system metastases