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New drug combo aims to match standard care in colorectal cancer battle

NCT ID NCT07595276

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tests whether a new drug called Enlituo, combined with chemotherapy (FOLFOX), works as well as the standard treatment Erbitux plus FOLFOX for people with advanced colorectal cancer that has specific genetic traits (RAS/BRAF wild-type and MSS/pMMR). About 608 adults will receive one of the two treatments every two weeks. The main goal is to see how many patients' tumors shrink within 16 weeks. This is not a cure, but aims to control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 608 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-Sen University Cancer Center

    Guangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.