Can a biosimilar match vectibix in colorectal cancer treatment?
NCT ID NCT07829588
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether QL1203, a proposed biosimilar of the drug Vectibix (panitumumab), behaves similarly in the body to the original Vectibix when both are combined with chemotherapy (mFOLFOX6). The trial enrolls adults with RAS wild-type metastatic colorectal cancer that cannot be treated with surgery or other local therapies. Participants receive either QL1203 or Vectibix plus chemotherapy, and researchers compare how the drugs move through the body, their safety, immune responses, and early signs of effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QL1203, a proposed biosimilar of the drug panitumumab
- What this could lead to
- If QL1203 behaves like Vectibix in the body, it could offer another version of this targeted colorectal cancer drug, potentially widening access.
- What could go wrong
- This is an early phase 1 study focused on how the drug moves through the body, not on whether it cures cancer. Biosimilars can fail to match the original drug closely enough, and the trial may not show equivalent behavior.
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 136 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 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 100 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: * Voluntarily participate, have read, understood and signed the informed consent form (ICF), and are able to follow the study procedures. * Male or female aged ≥18 years. * Metastatic colorectal adenocarcinoma confirmed by histology or cytology, and not suitable for radical surgery, radiotherapy, radiofrequency ablation and other local treatments. * Wild-type RAS and wild-type BRAF. * At least 1 definite measurable tumor lesion according to RECIST v1.1. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1. * Have adequate organ function. Exclusion Criteria: * Previous systemic treatment: The time from the last dose of neoadjuvant or adjuvant therapy to disease recurrence is \> 6 months. * Previous treatment with epidermal growth factor receptor (EGFR) targeted drugs for colorectal cancer. * Trial participants known to have high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). * Presence of active central nervous system metastases. * Participants with a history of malignancies other than colorectal cancer within 5 years prior to the first dose. * Trial participants (both male and female) who are unwilling to accept effective contraception; female trial participants who are pregnant or breastfeeding.
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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.