Clinical trial · Interventional
Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial
With or withoutA140 + mFOLFOX6 Treat 1st Line mCRC in RAS Wide Type, Multicenter, Double-blind, Randomized, Controlled Phase III Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to adjustments in our R\&D strategy, we are discontinuing the 140-III-01 study and initiating the 140-III-02 study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KL-140 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- All eligible subjects will receive KL-140 in combination with mFOLFOX-6 chemotherapy regimen.
- interventionNames
- Drug: KL-140
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator
- description
- All eligible subjects will receive Placebo in combination with mFOLFOX-6 chemotherapy regimen.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) Time
- timeFrame
- Time Frame: Baseline up to 128 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available