A Phase 3 interventional study of CMAB009 and Irinotecan in Metastatic Colorectal Cancer, sponsored by Taizhou Mabtech Pharmaceutical Co.,Ltd. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Taizhou Mabtech Pharmaceutical Co.,Ltd · Phase 3, Interventional, and Treatment
Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009, can block tumor growth in different ways. Giving combination chemotherapy together with CMAB009 as first treatment after diagnosis of a metastatic colorectal cancer（first-line treatment）may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with CMAB009 is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in combination with a standard and effective chemotherapy FOLFIRI（5-Fluorouracil /Folinic acid plus Irinotecan）for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone.
Patients will be randomly assign in one of the two groups to either receive the combination chemotherapy alone or with CMAB009 and will then be treated until progression of the disease or unacceptable toxicity occurred. Regular efficacy assessments（every 8 weeks）based on imaging will be performed throughout the study together with regular safety assessments.
After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 520 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Taizhou Mabtech Pharmaceutical Co.,Ltd is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Hepatic, marrow, liver and renal function as follows:
Marrow: white blood cell count \<3.0 × 109/L with neutrophils\<1.5 × 109/L, platelet count\<100×109/L and hemoglobin\<90 g/L; Liver function: Total bilirubin >1.5 × upper limit of reference range; Aspartate transaminase (AST) and alanine transaminase (ALT) > 2.5 × upper limit of reference range , or> 5 × upper reference range in subjects with liver metastasis; Renal function: Serum creatinine >1.5 × upper limit of reference range, or creatinine clearance\<50 mL/min
Drug: CMAB009(recombinant chimeric anti-EGFR monoclonal antibody injection), will be administered every 7 days at an initial dose of 400mg/m\^2 and 250mg/m\^2 for subsequent infusions until progression of disease , withdrawal of consent, or unacceptable toxicity. Drug: Irinotecan bi-weekly irinotecan infusion of 180mg/m\^2 on Day 1. Drug: Folinic Acid infusion 400mg/m\^2 of folinic acid in on Day 1. Drug: 5-Fluorouracil bolus 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-48 h continuous infusion of 2400mg/m\^2. every 2 weeks until progression of disease , withdrawal of consent, or unacceptable toxicity.
Drug: CMAB009 · Drug: Irinotecan · Drug: Folinic acid · Drug: 5-fluorouracil
FOLFIRI Drug: Irinotecan bi-weekly irinotecan infusion of 180mg/m\^2 on Day 1. Drug: Folinic Acid infusion 400mg/m\^2 of folinic acid in on Day 1. Drug: 5-Fluorouracil bolus 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-48 h continuous infusion of 2400mg/m\^2. every 2 weeks until progression of disease , withdrawal of consent, or unacceptable toxicity.
Drug: Irinotecan · Drug: Folinic acid · Drug: 5-fluorouracil
for injection only
Also known as: Eribitux
for injection only
Also known as: Camptosar
for injection only
Also known as: leucovorin
for injection only
Also known as: Fluoroplex
Progression-Free Survival (PFS)
The PFS duration (in months) is determined by a specially authorized Independent Radiology Review Committee (IRaC) through blinded review of imaging data. It is defined as the time from randomization to the first confirmed progression of disease by imaging or death from any cause within 90 days after the last tumor assessment or randomization, whichever is later (equivalent to 1.5 times the interval between two consecutive tumor assessments).
Time frame: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.
Objective Response Rate (ORR)
The objective response rate is calculated as the percentage of evaluable subjects with complete response (CR) and partial response (PR) (ORR = CR + PR).
Time frame: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.
Overall Survival（OS）
Defined as the time from randomization to death (in months). For subjects still alive or lost to follow-up as of the data analysis cutoff date, survival is censored at the subject's last known alive time.
Time frame: From randomization until the end of the study, an average of 1 year.
Disease Control Rate (DCR)
Refers to the percentage of subjects with the best response of complete response (CR), partial response (PR), and stable disease (SD) according to RECIST 1.1 criteria (DCR = CR + PR + SD).
Time frame: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.
Time to Response (TTR)
For subjects with the best response of CR or PR according to RECIST 1.1 criteria, the time from randomization to the first occurrence of response (CR or PR) according to RECIST 1.1.
Time frame: Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.
Quality of Life Assessment Indicators
Quality of life assessment (QOL) is conducted using the EORTC QLQ-C30 questionnaire, with individual item categorical scores linearly transformed to a 0-100 scale.
Time frame: Assessments are conducted at baseline and subsequent visits every 8 weeks until withdrawal from the study and entry into the follow-up period.
Resection Rate of Hepatic Metastasis
The resection rate of hepatic metastasis is calculated as the number of subjects achieving complete resection (R0 resection) divided by the total number of subjects.
Time frame: From randomization to the end of study
Safety Endpoint
Drug exposure, All types of AEs and incidence rates, Mortality rate and causes of death, Safety laboratory tests, Vital signs and Immunogenicity.
Time frame: From enrollment to the end of study
Plan to share: No
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Taizhou Mabtech Pharmaceutical Co.,Ltd