New biosimilar aims to offer cheaper option for colorectal cancer

NCT ID NCT07543471

Not yet recruiting Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

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

MCRC

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