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New biosimilar aims to offer cheaper option for colorectal cancer

NCT ID NCT07543471

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 trial tests a new drug called HLX05-N, which is a biosimilar (a copy) of the cancer drug Erbitux, in 387 people with metastatic colorectal cancer. Participants will receive either HLX05-N or Erbitux (from the US or EU) along with standard chemotherapy. The study aims to see if HLX05-N works similarly, is safe, and produces a similar immune response. Results could lead to a more affordable treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cetuximab (HLX05-N, a biosimilar to Erbitux) plus chemotherapy (mFOLFOX6)
What this could lead to
If it works, this could provide a more affordable treatment option for metastatic colorectal cancer that is as effective as the current drug Erbitux.
What could go wrong
This is an early Phase 1 trial, so it is mainly checking safety and how the drug behaves in the body. It may not prove that HLX05-N works as well as Erbitux, and side effects are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 387 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

Apr 2028

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 to 75 years

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: * 1\. Participants must have signed and dated an IRB/IEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines, and is willing to comply with all study procedures and rules required by the protocol. 2\. Male or female aged 18-75 years (inclusive) when signing the ICF. 3. 18.5 kg/m2 ≤ Body mass index (BMI) ≤ 30 kg/m2 and 50kg ≤ Body weight ≤ 85kg. 4. Participants with a KRAS and NRAS wild type and with no BRAF V600E mutation mCRC. 5\. Participants have histologically or cytologically documented locally advanced (unresectable) or metastatic colorectal adenocarcinoma originating from the splenic flexure to the rectum (left colon and rectum). 6\. Has not previously received first-line systemic anti-tumor therapy (including systemic chemotherapy, molecular targeted therapy, biological therapy, and other investigational drugs) for recurrent or metastatic CRC Exclusion Criteria: * 1\. History of illicit drug use or alcohol abuse in the investigator's judgment within 12 months prior to screening. 2\. Prior treatment with VEGF pathway-targeted therapy, EGFR pathway-targeted therapy, or signal transduction inhibitors (e.g., tyrosine kinase inhibitors). 3\. Received radiotherapy within 6 months prior to randomization, with the exception of palliative radiotherapy for bone lesions completed more than 14 days prior to randomization. Radiotherapy covering more than 30% of the bone marrow area within 28 days prior to randomization is not permitted. 4\. Underwent any major surgery within 4 weeks prior to randomization, or has not fully recovered from any surgery (placement of a vascular access device is not considered a major or minor surgery). For this study, a major surgery is defined as a procedure requiring at least a 3-week recovery period before the participant can receive treatment under this protocol. 5\. Has had other active malignancies within 5 years prior to randomization. Participants with cured localized tumors, such as basal cell carcinoma in situ of the skin, squamous cell carcinoma in situ of the skin, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast carcinoma in situ, or thyroid carcinoma in situ, may be enrolled.

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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

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  1. 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 ↗

  2. A doctor treating you

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