Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

Shanghai Zhangjiang Biotechnology Limited Company512 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

512

Conditions

Metastatic Colorectal Cancer

Interventions

CMAB009 plus IrinotecanDRUG

Combined with irinotecan 180 mg/m2 every 2 weeks, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression

Irinotecan-only and sequential-CMAB009DRUG

First, irinotecan 180 mg/m2 every 2 weeks till PD occured, discontinue it; then, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall response rate

Tumor response was evaluated every 6 weeks and confirmed at least 4 weeks later

Time frame: Time to progression, assessed up to two years

Secondary Outcomes

Progression-free Survival

The study was designed to evaluate the PFS as second end point, progression-free survival is defined as the period from date of randomization to date of disease progression

Time frame: Time to progression, assessed up to two years

Data from ClinicalTrials.gov

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