EGFR OverexpressionPhase 1NCT06309043
A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects
A Phase 1 study testing recombinant anti-EGFR human/murine chimeric monoclonal antibody injection in people with EGFR Overexpression, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- EGFR Overexpression
- What is being tested?
- recombinant anti-EGFR human/murine chimeric monoclonal antibody injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to 31 Dec 2026
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Males aged 18-50 years (inclusive); 2. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI between 18.5 and 28.0 (inclusive), and body weight of male subjects ≥ 50 kg; 3. Subjects without abnormalities or those with abnormalities with no clinical significance in terms of vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, serum chemistry, infectious disease indicators, coagulation function, cardiac markers, alcohol screening, drug screening, etc.), 12-lead ECG examination, chest X-ray, and abdominal B ultrasound; 4. Subjects who voluntarily take effective contraceptive measures and have no sperm donation plan during the screening period and within 3 months after drug administration, and voluntarily take non-drug contraceptive measures during the trial; 5. After fully understanding the content of the trial and possible adverse reactions, the subjects who voluntarily participate in the trial, are willing to sign the informed consent form (ICF), and are able to complete the study in accordance with the trial protocol.
Who cannot join
- With allergic constitution, or history of food or drug allergy; known history of allergy to any ingredient of the study drug or excipients or monoclonal antibody agents; history of infusion reactions;
- Subjects with a history of cardiovascular, respiratory, endocrine, hepatic, renal, gastrointestinal, nervous system, or hematological, immunological, psychiatric, metabolic obvious abnormalities, skin diseases, or other significant diseases, and are judged by the investigator as unsuitable for participating in the trial;
- Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders;
- With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
- With a history of surgery within 3 months prior to screening, or planned surgery during the trial;
- Intolerant to venipuncture or with a history of needle or blood phobia;
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- With a history of drug abuse within 6 months prior to screening;
- Use of narcotics within 3 months prior to screening;
- Subjects who have donated blood including blood components or lost blood (≥ 200 mL), received blood transfusion, or used blood products within 3 months prior to screening;
- Subjects who have received anti-EGFR targeted drugs (including monoclonal antibodies and TKIs) or other monoclonal antibodies within 3 months prior to screening;
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts.
- Conditions
- EGFR Overexpression
- Being tested
- recombinant anti-EGFR human/murine chimeric monoclonal antibody injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant anti-EGFR human/murine chimeric monoclonal antibody injectionDrug
a single dose，250 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| HLX05 | Experimental | Not described Receives: Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection |
| EU-sourced Erbitux | Active comparator | Not described Receives: Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection |
| US-sourced Erbitux | Active comparator | Not described Receives: Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection |
| CN-sourced Erbitux | Active comparator | Not described Receives: Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Area under the serum concentration-time curve from time 0 to infinity
Measured: 0 to Day 29
Secondary outcomes (4)
Cmax
Maximum serum concentration
Measured: 0 to Day 29
Tmax
Time to reach maximum serum concentration
Measured: 0 to Day 29
CL
Total clearance
Measured: 0 to Day 29
λz
Apparent terminal elimination rate constant
Measured: 0 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start22 Apr 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR OverexpressionStudies 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
- 268 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
- NCT06309043
- Sponsor's protocol ID
- HLX05-001
- Status last verified
- Jun 2024
- First submitted
- 7 Mar 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects
- ClinicalTrials.gov ID
- NCT06309043
- Acronym / sponsor ID
- HLX05-001
- Conditions
- EGFR Overexpression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2024 (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 randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLX05 | Experimental | Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection |
| EU-sourced Erbitux | Active comparator | Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection |
| US-sourced Erbitux | Active comparator | Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection |
| CN-sourced Erbitux | Active comparator | Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Males aged 18-50 years (inclusive); 2. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI between 18.5 and 28.0 (inclusive), and body weight of male subjects ≥ 50 kg; 3. Subjects without abnormalities or those with abnormalities with no clinical significance in terms of vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, serum chemistry, infectious disease indicators, coagulation function, cardiac markers, alcohol screening, drug screening, etc.), 12-lead ECG examination, chest X-ray, and abdominal B ultrasound; 4. Subjects who voluntarily take effective contraceptive measures and have no sperm donation plan during the screening period and within 3 months after drug administration, and voluntarily take non-drug contraceptive measures during the trial; 5. After fully understanding the content of the trial and possible adverse reactions, the subjects who voluntarily participate in the trial, are willing to sign the informed consent form (ICF), and are able to complete the study in accordance with the trial protocol.
Key exclusion criteria (10 listed)
- With allergic constitution, or history of food or drug allergy; known history of allergy to any ingredient of the study drug or excipients or monoclonal antibody agents; history of infusion reactions;
- Subjects with a history of cardiovascular, respiratory, endocrine, hepatic, renal, gastrointestinal, nervous system, or hematological, immunological, psychiatric, metabolic obvious abnormalities, skin diseases, or other significant diseases, and are judged by the investigator as unsuitable for participating in the trial;
- Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders;
- With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
- With a history of surgery within 3 months prior to screening, or planned surgery during the trial;
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 |
|---|---|---|
| recombinant anti-EGFR human/murine chimeric monoclonal antibody injectiona single dose，250 mg/m2 | Drug | CN-sourced Erbitux, EU-sourced Erbitux, HLX05, US-sourced Erbitux |
Primary outcome
AUC0-inf
Time frame: 0 to Day 29
Area under the serum concentration-time curve from time 0 to infinity
4 secondary outcomes
Cmax
Time frame: 0 to Day 29
Tmax
Time frame: 0 to Day 29
CL
Time frame: 0 to Day 29
λz
Time frame: 0 to Day 29
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 17 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant anti-EGFR human/murine chimeric monoclonal antibody injection in people with EGFR Overexpression, run by Shanghai Henlius Biotech at 1 site in China.
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 1 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf (time frame: 0 to Day 29). 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 17 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.