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Metastatic Colorectal CancerPhase 3NCT04835142

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

A Phase 3 study testing Open single period A140 in people with Metastatic Colorectal Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Open single period A140
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
688 participants
Where
1 siteChina
Study dates
31 Dec 2020to 26 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
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  • 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).

Who cannot join

  • 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；
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  • 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:
  • Receiving other anti-tumor treatments (including anti-tumor treatments with traditional Chinese medicines, such as Aidi injection, Kanglaite injection, Kangai injection, cininobufosin, brucea javanica oil, etc.) within 4 weeks before the first administration of the study ；
  • Long-term systemic immunotherapy, or hormone therapy for anti-tumor purposes (physiological replacement therapy, except for those with hypothyroidism who take thyroxine);
  • Have received G-CSF, GM-CSF, whole blood or blood component transfusions within 4 weeks before the first medication of the study;
  • Have received other experimental drugs or interventional clinical studies within 4 weeks before the first medication of the study；
  • Pregnancy (confirmed by blood pregnancy test) or lactation；
  • There is currently alcohol or drug dependence；
  • There is a clear neurological disease or mental illness that has not been cured, including epilepsy, dementia, schizophrenia, etc；
  • Adverse events of previous treatment (except for hair loss) did not return to grade 1 or below (NCI-CTCAE version 5.0)；
  • The researcher believes that the patient has other factors that affect the efficacy or safety evaluation of this study

Trial locations and contacts

1 site in 1 country.

China1 site

  • 307 Hospital of PLA

    Beijing, Beijing Municipality, 100071

Other trials in China

About this study

Official title: Phase III Clinical Study Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC

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

Read the detailed description

In this study, a multicenter, randomized, double-blind, controlled trial design was used to compare the efficacy and safety of A140 or Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer patients

Objective to compare the 12 week objective response rate (ORR) of A140 and ebitur combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer.

Being tested
Double blind control period A140, Open single period A140
Keywords
RAS wild-type, metastatic colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double blind control period A140Drug

    Also called KL-140

    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)

  • Open single period A140Drug

    Also called KL-140

    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)

Study groups in NCT04835142
Study groupRoleWhat they receive
Double blind control periodExperimentalexperiment 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.
Receives: Drug: Double blind control period A140
Open single periodExperimentalAll eligible subjects will receive A140 in combination with mFOLFOX-6 chemotherapy regimen every 2 weeks.
Receives: Drug: Open single period A140

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 16 Weeks

Secondary outcomes (5)

  1. ORR

    1)Based on the researcher's assessment of the objective tumor response rate (ORR) of patients with colorectal cancer after 12 weeks of medication, and confirmed at least 4 weeks later

    Measured: 16 Weeks

  2. Progression-free survival (PFS)

    2)PFS within 1 year after medication based on the evaluation by the independent imaging evaluation committee and the investigator

    Measured: PFS-1 year

  3. Overall survival (OS)

    1. OS within 1 year after medication based on the evaluation by the independent imaging evaluation committee and the investigator

    Measured: OS-1year

  4. Progression-free survival (PFS)

    3)Based on the researcher's assessment of PFS after 1 year of medication

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

  5. Overall survival (OS)

    3)Based on the researcher's assessment of OS after 1 year of medication

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start31 Dec 2020
  3. Primary completion22 Mar 2023
  4. Study completion26 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
688 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835142
Sponsor's protocol ID
KL140-Ⅲ-02-CTP
Status last verified
May 2026
First submitted
15 Mar 2021
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40737898

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Open single period A140 in people with Metastatic Colorectal Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835142, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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