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
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