CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer

NCT03206151 | Completed Phase 3

• 1 other identifier: 009mCRCIIIP
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.

• Overall Survival（OS）

  From randomization until the end of the study, an average of 1 year.

• Disease Control Rate (DCR)

  Tumor assessments are conducted every 8 weeks after randomization until the end of the study, an average of 1 year.

• Time to Response (TTR)

  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

  Assessments are conducted at baseline and subsequent visits every 8 weeks until withdrawal from the study and entry into the follow-up period.

Study Arms (2)

CMAB009 + FOLFIRI

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

CMAB009 DRUG

for injection only

Also known as: Eribitux

CMAB009 + FOLFIRI

Irinotecan DRUG

for injection only

Also known as: Camptosar

CMAB009 + FOLFIRI; FOLFIRI

Folinic acid DRUG

for injection only

Also known as: leucovorin

CMAB009 + FOLFIRI; FOLFIRI

5-fluorouracil DRUG

for injection only

Also known as: Fluoroplex

CMAB009 + FOLFIRI; FOLFIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, Aged ≥18 years and ≤75 years
• Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
• First occurrence of metastatic disease(not curatively resected)
• RAS/BRAF wild-type status in tumor tissue
• At least one measurable lesion by computer tomography(CT) or magnetic resonance imaging (MRI)according to RECIST1.1 criteria (not in an irradiated area)
• Eastern Cooperative Oncology Group(ECOG)performance status of 0 or 1 at trial entry
• Life expectancy of at least 3 months
• Medically accepted effective contraception if procreative potential exists(applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)
• Recovery from relevant toxicity due to previous treatment before trial entry
• Signed the informed consent form voluntarily

You may not qualify if:

• Radiotherapy or surgery（excluding prior diagnostic biopsy）in the 30 days before trial treatment
• 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
• Previous chemotherapy for CRC adjuvant treatment if terminated \<12 months before diagnosis of recurrence or metastatic disease
• Previous treatment with anti-EGFR monoclonal antibody, epidermal growth factor receptor tyrosine kinase inhibitor, or other EGFR targeted inhibitors(such as cetuximab, Nimotuzumab, or panitumumab)
• Known hypersensitivity or allergic reactions against any of the components of the trial treatments
• History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
• Other non-permitted concomitant anti-cancer therapies
• Known brain metastasis and/or leptomeningeal disease
• Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
• Participation in another clinical trial within the past 30 days
• Concurrent chronic systemic immune therapy or hormone therapy except physiologic replacement
• Any unstable systemic disease, such as active infection, uncontrolled hypertension, unstable angina pectoris, angina in the last 3 months, cardiac failure of New York Heart Association classes ≥II, history of myocardial infarction, serious cardiac arrhythmias that require drug treatment, liver, kidney or metabolic disease in the last 6 months
• Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
• severe bone marrow function failure

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (2)

Cancer hospital Chinese academy of medical sciences

Beijing, Beijing Municipality, 100021, China

Location

Tianjing medical university cancer institute and hospital

Tianjin, Tianjin Municipality, 300000, China

Location

Related Publications (1)

• Shi Y, Ba Y, Wang J, Xiong J, Gu K, Chen Y, Zheng Z, Wang Z, Guo W, Cheng Y, Yin X, Liu Y, Bai Y, Li E, Li Q, Zhu L, Li W, Jiang D, He J, Chen J, Sun J, Hou S. First-line treatment of anti-EGFR monoclonal antibody cetuximab beta plus FOLFIRI versus FOLFIRI alone in Chinese patients with RAS/BRAF wild-type metastatic colorectal cancer: a randomized, phase 3 trial. Signal Transduct Target Ther. 2025 May 7;10(1):147. doi: 10.1038/s41392-025-02229-4.

  PMID: 40328753 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CMAB009; Irinotecan; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yuankai Shi Professor, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Yi Ba Professor, Ph.D

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: December 12, 2017
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)