New biosimilar aims to offer cheaper option for colorectal cancer
NCT ID NCT07543471
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 387 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Step PET scan aims to spot hidden colorectal cancer spread
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can an antimalarial drug boost immunotherapy against colorectal cancer?