Metastatic Colorectal CancerPhase 3NCT03426371
Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial
A Phase 3 study testing KL-140 in people with Metastatic Colorectal Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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). 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?
- KL-140
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2018to 27 Nov 2021
- 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
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: With or withoutA140 + mFOLFOX6 Treat 1st Line mCRC in RAS Wide Type, Multicenter, Double-blind, Randomized, Controlled Phase III Trial
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
- Metastatic Colorectal Cancer
- Being tested
- KL-140, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL-140Drug
KL-140 will be administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity to KL-140.
Drug: Oxaliplatin Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: Folinic Acid FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: 5Fluorouracil 5-FU as a bolus of 400 mg/m^2/day intravenously followed by 2400 mg/m^2/day infusion over 48 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
PlaceboDrug
Placebo will be administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity Drug: Oxaliplatin Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: Folinic Acid FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
Drug: 5Fluorouracil 5-FU as a bolus of 400 mg/m^2/day intravenously followed by 2400 mg/m^2/day infusion over 48 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All eligible subjects will receive KL-140 in combination with mFOLFOX-6 chemotherapy regimen. Receives: Drug: KL-140 |
| Placebo Comparator | Placebo comparator | All eligible subjects will receive Placebo in combination with mFOLFOX-6 chemotherapy regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Time
PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the investigators according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.
Measured: Time Frame: Baseline up to 128 weeks
Secondary outcomes (4)
Overall Survival (OS) Time
OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.
Measured: Time Frame: Baseline up to 258 weeks
Best Overall Response Rate (ORR)
The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.
The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the investigators. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.
Measured: Time Frame: Baseline up to 128 weeks
Time to Treatment Failure (TTF)
TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD. Clinical PD according to the Investigator's assessment , discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment.
Measured: Time Frame: Baseline up to 128 weeks
quality of life score
Quality of life score is defined of questionnaire EORTC QLQ-C30.
Measured: Time Frame: Baseline up to 258 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start18 Mar 2018
- Primary completion27 Nov 2021
- Study completion27 Nov 2021
Why it stopped: Due to adjustments in our R\&D strategy, we are discontinuing the 140-III-01 study and initiating the 140-III-02 study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- multicenter, double-blind, randomized, controlled phase III trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426371
- Sponsor's protocol ID
- KL140-III-01
- Status last verified
- May 2026
- First submitted
- 24 Jan 2018
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- With or withoutA140 + mFOLFOX6 Treat 1st Line mCRC in RAS Wide Type, Multicenter, Double-blind, Randomized, Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT03426371
- Acronym / sponsor ID
- KL140-III-01
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to adjustments in our R\&D strategy, we are discontinuing the 140-III-01 study and initiating the 140-III-02 study.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2018 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 27 Nov 2021 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- multicenter, double-blind, randomized, controlled phase III trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: KL-140All eligible subjects will receive KL-140 in combination with mFOLFOX-6 chemotherapy regimen. |
| Placebo Comparator | Placebo comparator | Drug: PlaceboAll eligible subjects will receive Placebo in combination with mFOLFOX-6 chemotherapy regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KL-140KL-140 will be administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity to KL-140. Drug: Oxaliplatin Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity. Drug: Folinic Acid FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity. Drug: 5Fluorouracil 5-FU as a bolus of 400 mg/m^2/day intravenously followed by 2400 mg/m^2/day infusion over 48 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity. | Drug | Experimental |
| PlaceboPlacebo will be administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity Drug: Oxaliplatin Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity. Drug: Folinic Acid FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity. Drug: 5Fluorouracil 5-FU as a bolus of 400 mg/m^2/day intravenously followed by 2400 mg/m^2/day infusion over 48 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity. | Drug | Placebo Comparator |
Primary outcome
Progression Free Survival (PFS) Time
Time frame: Time Frame: Baseline up to 128 weeks
PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the investigators according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.
4 secondary outcomes
Overall Survival (OS) Time
Time frame: Time Frame: Baseline up to 258 weeks
Best Overall Response Rate (ORR)
Time frame: Time Frame: Baseline up to 128 weeks
Time to Treatment Failure (TTF)
Time frame: Time Frame: Baseline up to 128 weeks
quality of life score
Time frame: Time Frame: Baseline up to 258 weeks
Results and safety
The study was stopped early (reason given: Due to adjustments in our R\&D strategy, we are discontinuing the 140-III-01 study and initiating the 140-III-02 study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KL-140 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 10 inclusion and 23 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: stopped early, as of the sponsor's last update on 12 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Due to adjustments in our R\&D strategy, we are discontinuing the 140-III-01 study and initiating the 140-III-02 study.). Results are not available in the source record.
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?
Progression Free Survival (PFS) Time (time frame: Time Frame: Baseline up to 128 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.