mCRCPhase 1PK similarityNCT07543471
A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer
A Phase 1 study testing Cetuximab and mFOLFOX6 in people with mCRC, run by Shanghai Henlius Biotech.
Trial summary
This is a multicentre, randomized, double-blind, parallel-controlled Phase 1 clinical study designed to evaluate the pharmacokinetic (PK) similarity, efficacy, safety, and immunogenicity of HLX05-N compared with US-sourced ERBITUX® and EU-sourced ERBITUX® in participants with metastatic colorectal cancer (mCRC) with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- mCRC
- What is being tested?
- Cetuximab and mFOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicentre, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic, Efficacy, Safety, and Immunogenicity Profiles of HLX05-N vs. ERBITUX® (US/EU-sourced) in Participants With Metastatic Colorectal Cancer
This is a multicentre, randomized, double-blind, parallel-controlled Phase 1 clinical study designed to evaluate the pharmacokinetic (PK) similarity, efficacy, safety, and immunogenicity of HLX05-N compared with US-sourced ERBITUX® and EU-sourced ERBITUX® in participants with metastatic colorectal cancer (mCRC) with wild-type KRAS/NRAS and no BRAF V600E mutation.
Approximately 387 participants will be randomized in a 1:1:1 ratio to receive HLX05-N, US-ERBITUX®, or EU-ERBITUX®. Randomization will be stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) and sex (male vs. female).
Read more
During the treatment period, participants will receive study treatment in combination with mFOLFOX6 chemotherapy. For the first 3 treatment cycles, participants will receive HLX05-N or US-/EU-ERBITUX® plus chemotherapy according to randomized assignment. After completion of the initial 3 cycles, participants originally assigned to the US-ERBITUX® or EU-ERBITUX® arms will switch, in a blinded manner, to HLX05-N 250 mg/m² administered in combination with chemotherapy on Day 1 of each cycle. Study treatment will continue until investigator-assessed disease progression, death, initiation of new anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent, study termination, or 1 year after randomization, whichever occurs first.
For participants with disease response or stable disease after 12 cycles of treatment, oxaliplatin may be discontinued, and maintenance therapy with cetuximab in combination with leucovorin and 5-fluorouracil may continue. Participants who continue to benefit from treatment after 1 year following randomization may receive subsequent therapy according to local clinical practice.
PK and anti-drug antibody (ADA) samples will be collected from all participants to assess PK characteristics and immunogenicity. An end-of-treatment visit will be performed within 7 days after treatment discontinuation. Safety follow-up will be conducted 30 days after the last dose, with an additional telephone safety follow-up at 12 weeks after the last dose. Survival follow-up will continue for up to 1 year after randomization.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
400 mg/m2 administered as about 120-minute intravenous infusion on the first day of treatment. If the first infusion is well tolerated, then 250 mg/m2 intravenous infusion in about 1 hour weekly
mFOLFOX6Drug
Oxaliplatin, Leucovorin, 5-FU
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | HLX05-N Receives: Drug: Cetuximab; Drug: mFOLFOX6 |
| US-sourced Erbitux® | Active comparator | US-ERBITUX® Receives: Drug: Cetuximab; Drug: mFOLFOX6 |
| EU-sourced Erbitux® | Active comparator | EU-ERBITUX® Receives: Drug: Cetuximab; Drug: mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Area under the serum concentration-time curve from time 0 to 7 days (AUC0-7d) after the 1st dose
Measured: day 0 to day 7 after the 1st dose
Area under the serum concentration-time curve within a dosing interval at steady state (AUCss) after the 3rd dose
Measured: from 0 to 21 days
Secondary outcomes (5)
maximum serum drug concentration (Cmax)
Measured: from day 0 to week 51
Objective response rate (ORR) assessed by the Investigators (based on RECIST v1.1)
Measured: from day 0 to week 51
Time to response (TTR) assessed by the Investigators (based on RECIST v1.1)
Measured: from day 0 to week 51
Adverse Events (AEs)
Measured: from day 0 to week 51
Incidence of anti-drug antibody (ADA)
Measured: from day 0 to week 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mCRCStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543471
- Sponsor's protocol ID
- HLX05-N-mCRC102
- Acronym
- PK similarity
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in this study, the study protocol, and statistical analysis plan may be made available.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic, Efficacy, Safety, and Immunogenicity Profiles of HLX05-N vs. ERBITUX® (US/EU-sourced) in Participants With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07543471
- Acronym / sponsor ID
- PK similarity / HLX05-N-mCRC102
- Conditions
- mCRC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre, randomized, double-blind, parallel-controlled Phase 1 clinical study designed to evaluate the pharmacokinetic (PK) similarity, efficacy, safety, and immunogenicity of HLX05-N compared with US-sourced ERBITUX® and EU-sourced ERBITUX® in participants with metastatic colorectal cancer (mCRC) with wild-type KRAS/NRAS and no BRAF V600E mutation.
Approximately 387 participants will be randomized in a 1:1:1 ratio to receive HLX05-N, US-ERBITUX®, or EU-ERBITUX®. Randomization will be stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) and sex (male vs. female).
During the treatment period, participants will receive study treatment in combination with mFOLFOX6 chemotherapy. For the first 3 treatment cycles, participants will receive HLX05-N or US-/EU-ERBITUX® plus chemotherapy according to randomized assignment. After completion of the initial 3 cycles, participants originally assigned to the US-ERBITUX® or EU-ERBITUX® arms will switch, in a blinded manner, to HLX05-N 250 mg/m² administered in combination with chemotherapy on Day 1 of each cycle. Study treatment will continue until investigator-assessed disease progression, death, initiation of new anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent, study termination, or 1 year after randomization, whichever occurs first.
For participants with disease response or stable disease after 12 cycles of treatment, oxaliplatin may be discontinued, and maintenance therapy with cetuximab in combination with leucovorin and 5-fluorouracil may continue. Participants who continue to benefit from treatment after 1 year following randomization may receive subsequent therapy according to local clinical practice.
PK and anti-drug antibody (ADA) samples will be collected from all participants to assess PK characteristics and immunogenicity. An end-of-treatment visit will be performed within 7 days after treatment discontinuation. Safety follow-up will be conducted 30 days after the last dose, with an additional telephone safety follow-up at 12 weeks after the last dose. Survival follow-up will continue for up to 1 year after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Cetuximab, Drug: mFOLFOX6HLX05-N |
| US-sourced Erbitux® | Active comparator | Drug: Cetuximab, Drug: mFOLFOX6US-ERBITUX® |
| EU-sourced Erbitux® | Active comparator | Drug: Cetuximab, Drug: mFOLFOX6EU-ERBITUX® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab400 mg/m2 administered as about 120-minute intravenous infusion on the first day of treatment. If the first infusion is well tolerated, then 250 mg/m2 intravenous infusion in about 1 hour weekly | Drug | EU-sourced Erbitux®, Treatment group, US-sourced Erbitux® |
| mFOLFOX6Oxaliplatin, Leucovorin, 5-FU | Drug | EU-sourced Erbitux®, Treatment group, US-sourced Erbitux® |
Primary outcome
• Area under the serum concentration-time curve from time 0 to 7 days (AUC0-7d) after the 1st dose
Time frame: day 0 to day 7 after the 1st dose
Area under the serum concentration-time curve within a dosing interval at steady state (AUCss) after the 3rd dose
Time frame: from 0 to 21 days
5 secondary outcomes
maximum serum drug concentration (Cmax)
Time frame: from day 0 to week 51
Objective response rate (ORR) assessed by the Investigators (based on RECIST v1.1)
Time frame: from day 0 to week 51
Time to response (TTR) assessed by the Investigators (based on RECIST v1.1)
Time frame: from day 0 to week 51
Adverse Events (AEs)
Time frame: from day 0 to week 51
Incidence of anti-drug antibody (ADA)
Time frame: from day 0 to week 51
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in this study, the study protocol, and statistical analysis plan may be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cetuximab and mFOLFOX6 in people with mCRC, run by Shanghai Henlius Biotech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuyu Yang (021-33395800, Fuyu_Yang@Henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Area under the serum concentration-time curve from time 0 to 7 days (AUC0-7d) after the 1st dose (time frame: day 0 to day 7 after the 1st dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.