Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC

NCT04835142 | Completed Phase 3

• 1 other identifier: KL140-Ⅲ-02-CTP
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the objective remission rate of A140 and Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer for 12 weeks

Conditions

Metastatic Colorectal Cancer

Keywords

RAS wild-type; metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  The objective tumor response rate (ORR) of colorectal cancer patients at 12 weeks based on the evaluation of the independent imaging evaluation committee, and confirmed at least 4 weeks later

  16 Weeks

Secondary Outcomes (5)

• ORR

  16 Weeks

• Progression-free survival (PFS)

  PFS-1 year

• Overall survival (OS)

  OS-1year

• Progression-free survival (PFS)

  PFS-1 year after the last patient's first dose

• Overall survival (OS)

  OS-1 year after the last patient's first dose

Study Arms (2)

Double blind control period

EXPERIMENTAL

experiment arm： All eligible subjects will receive A140 in combination with mFOLFOX-6 chemotherapy regimen every 2 weeks. control arm: All eligible subjects will receive Erbitux in combination with mFOLFOX-6 chemotherapy regimen every 2 weeks.

Drug: Double blind control period A140

Open single period

EXPERIMENTAL

All eligible subjects will receive A140 in combination with mFOLFOX-6 chemotherapy regimen every 2 weeks.

Drug: Open single period A140

Interventions

Double blind control period A140 DRUG

experiment arm： Drug A140:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv), Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h) control arm: Drug Erbitux:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv) Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h)

Also known as: KL-140

Double blind control period

Open single period A140 DRUG

Drug A140:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv), Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h)

Also known as: KL-140

Open single period

Eligibility Criteria

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

You may qualify if:

• Be able to understand the procedures and methods of this study, be willing to strictly abide by the clinical trial protocol to complete this trial, and sign the informed consent voluntarily
• Male or female subjects aged 18-75 years (including 18 and 75 years)
• Histologically proven diagnosis of metastatic colorectal cancer. No previous systemic chemotherapy for metastatic colorectal cancer. Patients who have completed adjuvant chemotherapy before the start of the study can be enrolled, Platinum containing chemotherapy needs to end for more than 12 months, and non platinum containing chemotherapy needs to end for more than 6 months;
• KRAS and NRAS genotypes in tumor tissues were wild type, and BRAF-V600E mutation was not found；
• 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 16 weeks；
• The level of organ function before the first medication met the following requirements:
• Peripheral blood cell count: leukocyte count ≥ 3×10ˆ9 / L, neutrophil count ≥ 1.5× 10ˆ9 / L, platelet count ≥ 75 × 10ˆ9 / L, hemoglobin ≥ 90 g / L;
• Liver function: total bilirubin ≤ 1.5 ULN, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 ULN; AST and ALT≤ 5 ULN in subjects with liver metastasis;
• Renal function: serum creatinine ≤ 1.5 ULN.
• Fertile subjects (male and female) were required to receive effective medical contraceptive measures until 3 months after the last study (see Annex 4 for specific contraceptive measures).

You may not qualify if:

• Those who are known to have an allergic reaction to any component of the study drug；
• Local treatments such as radiotherapy, radiofrequency ablation, intervention, etc or surgical procedures (excluding prior diagnostic biopsy) in the 28 days before first administration；
• Known brain metastasis and/or leptomeningeal disease；
• People with complete intestinal obstruction and incomplete intestinal obstruction requiring treatment. However, patients whose obstruction is relieved by fistula or stent placement can be included in the group;
• Active severe clinical infection (\> Grade 2, NCI-CTCAE version 5.0), including active tuberculosis；
• Uncontrolled diabetes (fasting blood glucose ≥10 mmol/L), severe lung disease (such as acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease. Except for radiation pneumonia that has recovered), liver failure；
• Clinically significant cardiovascular diseases, such as heart failure (NYHAⅢ-Ⅳ), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, hypertension (systolic blood pressure\>150mmHg and/or diastolic blood pressure\>100mmHg), echocardiography The figure shows the ejection fraction \<50%, the history of myocardial infarction within the past two years；
• Renal replacement therapy；
• \> Grade 1 Peripheral Nerve Disorder (NCI-CTCAE Version 5.0)；
• 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；
• HIV infection, hepatitis B surface antigen positive (and peripheral blood hepatitis B virus deoxynucleotide HBV DNA ≥ 1×10ˆ4 copy number/ml or ≥ 2000 IU/ml), hepatitis C virus antibody positive (and peripheral blood hepatitis C virus nucleotide HCV RNA≥ 1×10ˆ3 copies/ml or ≥ 200 IU/ml)；
• Patients with coagulation dysfunction, meet any of the following conditions: prothrombin time (PT) ≥ 1.5 ULN， thrombin time (TT) ≥ 1.5 ULN,activated partial thromboplastin time (APTT) ≥ 1.5 ULN;
• Previously treatment with VEGF pathway targeted therapy and EGFR monoclonal antibody；
• Past treatment history:

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

Location

Related Publications (1)

• Liu R, Yin X, Bai Y, Zhong H, Ye F, Wang Q, Liu M, Li N, Deng Y, Wang Y, Xu J, Li W, Chen K, Cai S, Yang J, Zhang T, Li Y, Qin B, Deng L, Liu S, Li S, Si J, Li Y, Ge J, Xu N, Xu J. A140 plus mFOLFOX6 compared with cetuximab plus mFOLFOX6 for first-line RAS wild-type metastatic colorectal cancer: A randomized clinical trial. Eur J Cancer. 2025 Aug 26;226:115566. doi: 10.1016/j.ejca.2025.115566. Epub 2025 Jun 7.

  PMID: 40737898 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: April 8, 2021
• Study Start: December 31, 2020
• Primary Completion: March 22, 2023
• Study Completion: January 26, 2024
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

CN (1)