Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial


Kelun Pharmaceutical

Status and phase

Phase 3


Metastatic Colorectal Cancer


Drug: Placebo
Drug: KL-140

Study type


Funder types




Details and patient eligibility


The study is an double blind, randomized, multicenter phase 3 trial. The efficacy analyses are based on 570 Chinese patients with RAS wt mCRC treated with mFOLFOX-6 ± cetuximab. Study treatment continues until disease progression or unacceptable toxicity (ie, not for a fixed number of courses). The primary endpoint of the study is progression-free survival (PFS) time according to RECIST 1.0; key secondary endpoints include overall survival (OS) time, overall response rate (ORR), and safety/tolerability.


570 estimated patients




18 to 75 years old


No Healthy Volunteers

Inclusion criteria

  • Signed written informed consent
  • Male or female subjects, 18-75 years of age
  • Medically accepted effective contraception if procreative potential exists
  • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • RAS wild-type and BRAF-V600E wild-type status in tumor tissue
  • At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry
  • White blood cell count >= 3 × 10x9/L with neutrophils >= 1.5 × 10x9/L, platelet count >=75 × 10x9/L and hemoglobin >= 8 g/dL; 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;Serum creatinine <= 1.5 × upper limit of reference range

Exclusion criteria

  • Known hypersensitivity or allergic reactions against any of the components of the trial treatments
  • Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 28 days before trial treatment
  • Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease,except the patient with fistulation or stenting
  • Active clinically serious infections (> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis
  • Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram
  • Renal replacement therapy
  • Peripheral neuropathy > grade 1
  • History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
  • Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
  • Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Known severe coagulation disorders
  • Previous chemotherapy for CRC except adjuvant treatment if terminated > 12 months (oxaliplatin-based chemotherapy) or > 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial
  • Previous treatment with anti-EGFR monoclonal antibody therapy
  • Other non-permitted concomitant anticancer therapies, chronic systemic immune therapy or hormone therapy
  • Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry,blood transfusion,or blood components transfusion
  • Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding
  • Ongoing alcohol or drug abuse
  • Known neurological or psychiatric diseases
  • Participation in another clinical trial within the past 4 weeks
  • Legal incapacity or limited legal capacity
  • Other significant disease that in the investigator's opinion should exclude the subject from the trial

Trial design

Primary purpose




Interventional model

Parallel Assignment


Triple Blind

570 participants in 2 patient groups, including a placebo group

Experimental group
All eligible subjects will receive KL-140 in combination with mFOLFOX-6 chemotherapy regimen.
Drug: KL-140
Placebo Comparator
Placebo Comparator group
All eligible subjects will receive Placebo in combination with mFOLFOX-6 chemotherapy regimen.
Drug: Placebo

Trial contacts and locations



Data sourced from clinicaltrials.gov

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