Colorectal CancerPhase 3NCT07595276
Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.
A Phase 3 study testing Enlituo® and Erbitux® in people with Colorectal Cancer, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS/BRAF wild-type and MSS/pMMR locally advanced/metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Enlituo® and Erbitux®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2026to 1 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study and sign the informed consent form.
- Aged 18 years or older.
- Participants with histologically and/or cytologically confirmed locally advanced/metastatic colorectal cancer.
- Have at least one evaluable or measurable tumor target lesion (RECIST v1.1). Lesions that have received previous local therapy or locoregional therapy (e.g., radiotherapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous intervention) should not be considered measurable lesions unless progression is observed after the local or locoregional therapy.
- Have not received prior systemic anti-tumor therapy for locally advanced/metastatic colorectal cancer. Previous neoadjuvant or adjuvant therapy for colorectal cancer is allowed if completed ≥6 months before the detection of disease recurrence or metastasis.
- Have an ECOG performance status of 0 or 1.
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- Have a life expectancy of ≥12 weeks.
- Have locally advanced/metastatic colorectal cancer confirmed by a local laboratory to be RAS/BRAF wild-type and MSS/pMMR.
- Note: RAS wild-type refers to wild-type status for KRAS exons 2, 3, 4 and NRAS exons 2, 3, 4.
- -Have adequate organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 2 weeks prior to the first dose of study treatment).
- Hematology:
- Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹/L Platelets ≥100 × 10⁹/L Hemoglobin ≥90 g/L
- Liver Function :
- ALT and AST in participants without liver metastases ≤2.5 × Upper Limit of Normal (ULN) Serum Total Bilirubin in participants without liver metastases ≤1.5 × ULN ALT and AST in participants with liver metastases ≤5 × ULN Serum Total Bilirubin in participants with liver metastases or Gilbert's syndrome ≤3 × ULN
- Renal Function :
- Creatinine Clearance calculated by Cockcroft-Gault formula ≥50.0 mL/min Coagulation International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (aPTT) INR ≤1.5 or aPTT ≤1.5 × ULN (For participants receiving anticoagulant therapy, the investigator must judge the INR and/or aPTT to be within a safe and effective therapeutic range.)
- Cardiac Function:
- Left Ventricular Ejection Fraction (LVEF) measured by echocardiography or Multiple Gated Acquisition (MUGA) scan >50%
- Women of childbearing potential (WOCBP) must agree to use reliable contraceptive methods to avoid the risk of pregnancy throughout the study treatment period and for 180 days after the last dose of study treatment.
- WOCBP must have a negative serum pregnancy test result within 72 hours before the first dose of the investigational product.
- Female participants must not be breastfeeding.
- Male participants must agree to use reliable contraceptive methods from the first dose of study treatment until 180 days after the last dose of study treatment.
Who cannot join
- History of other active malignancies within the past 3 years, except for locally curable tumors deemed by the investigator to have a low risk of recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)
- Has not recovered from adverse events (AEs) due to prior anti-tumor therapy (i.e., not recovered to ≤ Grade 1 or to baseline, with the exception of alopecia, hypothyroidism controllable with hormone replacement therapy, and well-controlled type 1 diabetes on insulin therapy).
- Prior treatment with EGFR-targeted antibodies (e.g., cetuximab, panitumumab, etc.), antibody-drug conjugates (ADCs) (e.g., MRG003, SHR-A1307, RC-68, etc.), or signal transduction inhibitors (e.g., gefitinib, osimertinib, etc.).
- Currently participating in and receiving investigational drug therapy from another clinical trial, or has received investigational drug therapy or used an investigational device within 4 weeks prior to the first dose of study treatment (Note: this does not include the follow-up period of a study).
- Major surgery within 4 weeks prior to the first dose of study treatment, or open biopsy within 1 week prior. (Minor procedures such as mediastinoscopy, placement of a central venous access device, placement of a gastric tube, needle biopsy, and percutaneous nephrostomy are not considered major surgery).
- Any chemotherapy, immunotherapy, experimental therapy, or other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter, but at least 14 days) prior to the first dose of study treatment. Treatment with anti-tumor traditional Chinese medicine preparations or any radiotherapy within 2 weeks prior to the first dose of study treatment.
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- Known central nervous system metastases and/or carcinomatous meningitis. Ascites, pleural effusion, or pericardial effusion requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.
- Known active infection requiring systemic therapy administered intravenously within 2 weeks prior to the first dose of study treatment.
- History of active tuberculosis infection within 1 year. (Participants with a history of active tuberculosis may be eligible if the investigator judges there is no evidence of active tuberculosis for more than 1 year prior to the first dose of study treatment).
- History of non-infectious pneumonitis requiring oral or intravenous steroids to aid recovery, or history of pulmonary fibrosis, interstitial lung disease, radiation pneumonitis, drug-related pneumonitis, or other severe lung function impairment such as severe chronic obstructive pulmonary disease.
- Acute or subacute intestinal obstruction, or inflammatory bowel disease. Concomitant Diseases/Other Exclusion Criteria
- Known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Participants with active or chronic hepatitis B (HBsAg positive and HBV DNA ≥2000 IU/mL or ≥10,000 copies/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection. (Participants who are HBsAg positive or HBV-DNA positive at screening are recommended to receive antiviral therapy during the study according to clinical practice).
- Clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment, including but not limited to myocardial infarction, severe/unstable angina, primary cardiomyopathy, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), or congestive heart failure (New York Heart Association class > II); symptomatic coronary artery disease requiring medication; arrhythmia requiring medication; QTcF interval > 480 ms on electrocardiogram; or uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg despite adequate medication).
- Significant clinically significant bleeding symptoms or a definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, or vasculitis, within 6 months prior to the first dose of study treatment.
- Known hypersensitivity or allergic reaction to any component of the study treatment.
- History of allogeneic tissue/solid organ transplantation or graft-versus-host disease.
- Treatment with any live vaccine within 4 weeks prior to the first dose of study treatment (with the exception of live-attenuated vaccines).
- Known psychiatric or substance abuse disorder that would interfere with compliance with study requirements.
- Any underlying medical condition that, in the investigator's judgment, would make the administration of the study drug hazardous to the participant or would obscure the interpretation of toxicity or adverse events.
- Any other condition for which the investigator deems the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou
Ruihua Xu, +86(20)87343009, xurh@sysucc.org.cn
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase III Clinical Study Evaluating the Efficacy and Safety of Enlituo® Plus FOLFOX Versus Erbitux® Plus FOLFOX as First-line Treatment for Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.
This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS/BRAF wild-type and MSS/pMMR locally advanced/metastatic colorectal cancer.
Enrolled participants will be stratified according to ECOG performance status (0 vs. 1) and primary tumor location (left-sided or right-sided colon) and randomly assigned in a 1:1 ratio to either the experimental group (Enlituo® + FOLFOX) or the control group (Erbitux® + FOLFOX).
Read more
Participants will:
- Receive Enlituo®/Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks.
- Receive FOLFOX
- Participants in the Erbitux® plus FOLFOX group who achieve CR, PR, or SD at 16 weeks will cross over to receive Enlituo® plus FOLFOX.
- Be recommended to undergo efficacy assessments every 8 weeks (±7 days).
- Comply with the blood sample collection procedures for pharmacokinetic (PK) and immunogenicity analyses.
- Be required to provide baseline tumor biopsy specimens or 8-10 unstained slides of archived tumor tissue (formalin-fixed, paraffin-embedded) from within the past 3 years.
The Blinded Independent Central Review (BIRC) will assess:
- Objective Response Rate (ORR) within 16 weeks.
- Disease Control Rate (DCR) within 16 weeks.
- Duration of Response (DoR).
- Progression-Free Survival (PFS).
The investigators will assess:
- ORR within 16 weeks.
- DCR within 16 weeks.
- DoR.
- PFS.
- Overall Survival (OS).
- Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as findings from laboratory tests, vital signs, and physical examinations.
- Dose intensity, and incidence of dose interruptions, dose reductions, and treatment discontinuations due to AEs.
- Conditions
- Colorectal Cancer
- Being tested
- Enlituo®, Erbitux®
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlituo®Biological
Enlituo®:
500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks.
FOLFOX Regimen:
Oxaliplatin: 85 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks.
Leucovorin (LV): 400 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks.
5-Fluorouracil (5-FU): Bolus: 400 mg/m², administered via intravenous bolus, on Day 1 of each treatment cycle. Continuous Infusion: 1200 mg/(m²•day) for 2 days (total dose 2400 mg/m²), administered via continuous intravenous infusion over 46 to 48 hours, on Days 1 to 3 of each treatment cycle. One treatment cycle spans 2 weeks.
Erbitux®Biological
Erbitux®:
500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. Erbitux® will be administered for up to 16 weeks. Participants who continue to derive benefit (including SD, PR, and CR) after 16 weeks will crossover to receive Enlituo® combined with FOLFOX.
FOLFOX Regimen:
Oxaliplatin: 85 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks.
Leucovorin (LV): 400 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks.
5-Fluorouracil (5-FU): Bolus: 400 mg/m², administered via intravenous bolus, on Day 1 of each treatment cycle. Continuous Infusion: 1200 mg/(m²•day) for 2 days (total dose 2400 mg/m²), administered via continuous intravenous infusion over 46 to 48 hours, on Days 1 to 3 of each treatment cycle. One treatment cycle spans 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Enlituo® | Experimental | Enlituo® + FOLFOX Receives: Biological: Enlituo® |
| Erbitux® | Active comparator | Erbitux® + FOLFOX Receives: Biological: Erbitux® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) within 16 weeks assessed by BIRC according to RECIST v1.1 criteria
The sum of the Complete Response (CR) rate and the Partial Response (PR) rate
Measured: From enrollment to 16 weeks after the first dose.
Secondary outcomes (10)
Disease Control Rate (DCR) within 16 weeks assessed by BIRC according to RECIST v1.1 criteria
The proportion of patients whose tumor achieves a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) following treatment.
Measured: From enrollment to 16 weeks after the first dose.
Duration of Response (DoR) assessed by the BIRC according to RECIST v1.1 criteria
The time from the date of the first documented complete or partial response (whichever is recorded first) until the first documented disease progression or death from any cause, whichever occurs first.
Measured: From the date of CR/PR to the date of the first documented progression or death from any cause, whichever occurs first, assessed up to at least 12 months of treatment for the last participant.
Progression-Free Survival (PFS) assessed by the BIRC according to RECIST v1.1 criteria
The time from randomization until objective tumor progression or death from any cause, whichever came first.
Measured: From the date of randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to at least 12 months of treatment for the last participant.
Objective Response Rate (ORR) within 16 weeks assessed by the investigator according to RECIST v1.1 criteria
The sum of the Complete Response (CR) rate and the Partial Response (PR) rate
Measured: From enrollment to 16 weeks after the first dose.
Duration of Response (DoR) assessed by the investigator according to RECIST v1.1 criteria
The time from the date of the first documented complete or partial response (whichever is recorded first) until the first documented disease progression or death from any cause, whichever occurs first.
Measured: From the date of CR/PR to the date of the first documented progression or death from any cause, whichever occurs first, assessed up to at least 12 months of treatment for the last participant.
Progression-Free Survival (PFS) assessed by the investigator according to RECIST v1.1 criteria
The time from randomization until objective tumor progression or death from any cause, whichever came first.
Measured: From the date of randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to at least 12 months of treatment for the last participant.
Overall Survival (OS)
The time from randomization to death from any cause.
Measured: From the date of randomization until the date of death from any cause, assessed up to at least 12 months of treatment for the last participant.
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as findings from laboratory tests, vital signs, and physical examinations
Measured: From the time the participant signs the informed consent form until 30 days after the last dose of study treatment.
Plasma concentration of Enlituo®/Erbitux®
Measured: Cycle 1: Within 2 hours before the start of infusion, and within 15 minutes after the end of infusion. Cycle 2, 4, 8: Within 2 hours before the start of infusion (each cycle is 14 days). At the end of treatment, at least of 1 year.
Anti-drug antibody (ADA)
Measured: Cycle 1, 2, 4, 8: Within 2 hours before the start of infusion (each cycle is 14 days). At the end of treatment, at least of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start27 May 2026
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595276
- Sponsor's protocol ID
- SIM0669-302
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Phase III Clinical Study Evaluating the Efficacy and Safety of Enlituo® Plus FOLFOX Versus Erbitux® Plus FOLFOX as First-line Treatment for Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status.
- ClinicalTrials.gov ID
- NCT07595276
- Acronym / sponsor ID
- SIM0669-302
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 27 May 2026 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 19 May 2026 (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.
This is a randomized, double-blind, phase III clinical trial. The study aims to demonstrate that the treatment regimen of Enlituo® plus FOLFOX is equivalent to that of Erbitux® plus FOLFOX in participants with RAS/BRAF wild-type and MSS/pMMR locally advanced/metastatic colorectal cancer.
Enrolled participants will be stratified according to ECOG performance status (0 vs. 1) and primary tumor location (left-sided or right-sided colon) and randomly assigned in a 1:1 ratio to either the experimental group (Enlituo® + FOLFOX) or the control group (Erbitux® + FOLFOX).
Participants will:
- Receive Enlituo®/Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks.
- Receive FOLFOX
- Participants in the Erbitux® plus FOLFOX group who achieve CR, PR, or SD at 16 weeks will cross over to receive Enlituo® plus FOLFOX.
- Be recommended to undergo efficacy assessments every 8 weeks (±7 days).
- Comply with the blood sample collection procedures for pharmacokinetic (PK) and immunogenicity analyses.
- Be required to provide baseline tumor biopsy specimens or 8-10 unstained slides of archived tumor tissue (formalin-fixed, paraffin-embedded) from within the past 3 years.
The Blinded Independent Central Review (BIRC) will assess:
- Objective Response Rate (ORR) within 16 weeks.
- Disease Control Rate (DCR) within 16 weeks.
- Duration of Response (DoR).
- Progression-Free Survival (PFS).
The investigators will assess:
- ORR within 16 weeks.
- DCR within 16 weeks.
- DoR.
- PFS.
- Overall Survival (OS).
- Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as findings from laboratory tests, vital signs, and physical examinations.
- Dose intensity, and incidence of dose interruptions, dose reductions, and treatment discontinuations due to AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enlituo® | Experimental | Biological: Enlituo®Enlituo® + FOLFOX |
| Erbitux® | Active comparator | Biological: Erbitux®Erbitux® + FOLFOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Voluntarily participate in the study and sign the informed consent form.
- Aged 18 years or older.
- Participants with histologically and/or cytologically confirmed locally advanced/metastatic colorectal cancer.
- Have at least one evaluable or measurable tumor target lesion (RECIST v1.1). Lesions that have received previous local therapy or locoregional therapy (e.g., radiotherapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous intervention) should not be considered measurable lesions unless progression is observed after the local or locoregional therapy.
- Have not received prior systemic anti-tumor therapy for locally advanced/metastatic colorectal cancer. Previous neoadjuvant or adjuvant therapy for colorectal cancer is allowed if completed ≥6 months before the detection of disease recurrence or metastasis.
Key exclusion criteria (21 listed)
- History of other active malignancies within the past 3 years, except for locally curable tumors deemed by the investigator to have a low risk of recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast)
- Has not recovered from adverse events (AEs) due to prior anti-tumor therapy (i.e., not recovered to ≤ Grade 1 or to baseline, with the exception of alopecia, hypothyroidism controllable with hormone replacement therapy, and well-controlled type 1 diabetes on insulin therapy).
- Prior treatment with EGFR-targeted antibodies (e.g., cetuximab, panitumumab, etc.), antibody-drug conjugates (ADCs) (e.g., MRG003, SHR-A1307, RC-68, etc.), or signal transduction inhibitors (e.g., gefitinib, osimertinib, etc.).
- Currently participating in and receiving investigational drug therapy from another clinical trial, or has received investigational drug therapy or used an investigational device within 4 weeks prior to the first dose of study treatment (Note: this does not include the follow-up period of a study).
- Major surgery within 4 weeks prior to the first dose of study treatment, or open biopsy within 1 week prior. (Minor procedures such as mediastinoscopy, placement of a central venous access device, placement of a gastric tube, needle biopsy, and percutaneous nephrostomy are not considered major surgery).
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 |
|---|---|---|
| Enlituo®Enlituo®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. FOLFOX Regimen: Oxaliplatin: 85 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. Leucovorin (LV): 400 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. 5-Fluorouracil (5-FU): Bolus: 400 mg/m², administered via intravenous bolus, on Day 1 of each treatment cycle. Continuous Infusion: 1200 mg/(m²•day) for 2 days (total dose 2400 mg/m²), administered via continuous intravenous infusion over 46 to 48 hours, on Days 1 to 3 of each treatment cycle. One treatment cycle spans 2 weeks. | Biological | Enlituo® |
| Erbitux®Erbitux®: 500 mg/m², administered via intravenous infusion over a minimum of 120 minutes, once every two weeks. Erbitux® will be administered for up to 16 weeks. Participants who continue to derive benefit (including SD, PR, and CR) after 16 weeks will crossover to receive Enlituo® combined with FOLFOX. FOLFOX Regimen: Oxaliplatin: 85 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. Leucovorin (LV): 400 mg/m², administered via intravenous infusion over 2 hours, on Day 1 of each treatment cycle. One treatment cycle spans 2 weeks. 5-Fluorouracil (5-FU): Bolus: 400 mg/m², administered via intravenous bolus, on Day 1 of each treatment cycle. Continuous Infusion: 1200 mg/(m²•day) for 2 days (total dose 2400 mg/m²), administered via continuous intravenous infusion over 46 to 48 hours, on Days 1 to 3 of each treatment cycle. One treatment cycle spans 2 weeks. | Biological | Erbitux® |
Primary outcome
Objective Response Rate (ORR) within 16 weeks assessed by BIRC according to RECIST v1.1 criteria
Time frame: From enrollment to 16 weeks after the first dose.
The sum of the Complete Response (CR) rate and the Partial Response (PR) rate
10 secondary outcomes
Disease Control Rate (DCR) within 16 weeks assessed by BIRC according to RECIST v1.1 criteria
Time frame: From enrollment to 16 weeks after the first dose.
Duration of Response (DoR) assessed by the BIRC according to RECIST v1.1 criteria
Time frame: From the date of CR/PR to the date of the first documented progression or death from any cause, whichever occurs first, assessed up to at least 12 months of treatment for the last participant.
Progression-Free Survival (PFS) assessed by the BIRC according to RECIST v1.1 criteria
Time frame: From the date of randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to at least 12 months of treatment for the last participant.
Objective Response Rate (ORR) within 16 weeks assessed by the investigator according to RECIST v1.1 criteria
Time frame: From enrollment to 16 weeks after the first dose.
Duration of Response (DoR) assessed by the investigator according to RECIST v1.1 criteria
Time frame: From the date of CR/PR to the date of the first documented progression or death from any cause, whichever occurs first, assessed up to at least 12 months of treatment for the last participant.
Progression-Free Survival (PFS) assessed by the investigator according to RECIST v1.1 criteria
Time frame: From the date of randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to at least 12 months of treatment for the last participant.
Overall Survival (OS)
Time frame: From the date of randomization until the date of death from any cause, assessed up to at least 12 months of treatment for the last participant.
Incidence and severity of adverse events (AEs)
Time frame: From the time the participant signs the informed consent form until 30 days after the last dose of study treatment.
Plasma concentration of Enlituo®/Erbitux®
Time frame: Cycle 1: Within 2 hours before the start of infusion, and within 15 minutes after the end of infusion. Cycle 2, 4, 8: Within 2 hours before the start of infusion (each cycle is 14 days). At the end of treatment, at least of 1 year.
Anti-drug antibody (ADA)
Time frame: Cycle 1, 2, 4, 8: Within 2 hours before the start of infusion (each cycle is 14 days). At the end of treatment, at least of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Enlituo® and Erbitux® in people with Colorectal Cancer, run by Taizhou Mabtech Pharmaceutical 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 22 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 5 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang Guo (+86(25)85566666, guojiang@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) within 16 weeks assessed by BIRC according to RECIST v1.1 criteria (time frame: From enrollment to 16 weeks after the first dose.). 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 5 Oct 2026.