Recurrent or Metastatic Squamous Cell Carcinoma of Head and NeckPhase 2NCT04868162
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
A Phase 2 study testing MRG003 and MRG003+HX008 in people with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck, run by Lepu Biopharma Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- MRG003 and MRG003+HX008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2021to 26 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Willing to sign the ICF and follow the requirements specified in the protocol.
- Expected survival time≥3 months.
- Patients with histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of head and neck.
- Failed prior platinum and/or anti-PD-1 treatment (Part A); failed or intolerant to at least one prior line of standard therapy (platinum-based regimen) (Part B)
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- ECOG performance score 0 or 1.
Show all 9Show fewer
- Organ functions and coagulation function must meet the basic requirements.
- Serum or urine pregnancy test negative within 7 days before the first dose of investigational drug.
- Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
Who cannot join
- History of 4 or more systemic anti-tumor therapies for the recurrent or metastatic squamous cell carcinoma of head and neck.
- ≥Grade 2 peripheral neuropathy
- Prior anti-tumor therapy with MMAE/MMAF ADCs
- BMI≤17
- Expected surgery or any other form of systemic or local anti-tumor therapy.
- History of systemic chemotherapy within 3 weeks before the first administration of the investigational drug, targeted small molecule therapy within 2 weeks or 5 half-life periods before the first administration (whichever is shorter), antitumor biological therapy or immunotherapy within 4 weeks before the first administration, or major surgery.
Show all 25Show fewer
- Known active CNS metastasis and/or cancerous meningitis.
- Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values of laboratory tests higher than grade 1 (CTCAE v5.0). Prior Grade 3 to 4 immune-related AE (irAE) or ≥Grade 2 heart-related irAE.
- Uncontrolled or poorly controlled heart disease.
- History of pulmonary embolism or deep vein thrombosis within 3 months before the first administration of the investigational drug.
- Known history of malignancy.
- History of severe dermatosis.
- Uncontrolled or poorly controlled hypertension.
- Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy.
- Known allergic reaction to any ingredients or excipients of investigational drugs.
- Known active hepatitis B or C.
- Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation.
- Active bacterial, viral, fungal, rickettsia, or parasitic infections that require systemic anti-infective treatment.
- Vaccination of live virus vaccine within 30 days before the first administration of the study drug. Inactivated seasonal influenza vaccine or approved COVID-19 vaccine is allowed.
- History of previous or concurrent interstitial pneumonia, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary dysfunction, symptomatic bronchospasm, etc.
- Patients receiving immunology-based treatment for any reason.
- Uncontrolled pleural effusion, pericardial effusion or recurrent ascites.
- Potent CYP3A4 inhibitors or inducers are in use and cannot be discontinued.
- Women who are lactating or pregnant.
- Other conditions that in the clinical judgement of the investigator make the patient not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.
Read the detailed description
The study consists of two stages. In Part A, approximately 60 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003 at 2.0 and 2.3 mg/kg, to further explore the optimized dose. In Part B, 30 to 50 patients will be enrolled to evaluate the safety and preliminary efficacy of the combination of MRG003 and HX008.
- Being tested
- MRG003, MRG003+HX008
- Keywords
- MRG003, Squamous Cell Carcinoma of Head and Neck, EGFR, HX008, PD-1
- Medical subject headings
- Recurrence, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG003Drug
On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or 2.3 mg/kg.
MRG003+HX008Drug
On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or the recommended dose by SMC; and HX008 will be administered via intravenous infusion at 3.0 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | MRG003 monotherapy will be administered for patients enrolled into Part A of this study; MRG003 and HX008 combination will be administered for patients enrolled into Part B of this study. Receives: Drug: MRG003; Drug: MRG003+HX008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by Investigator per RECIST v1.1
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
Measured: Baseline to study completion (up to 24 months)
Secondary outcomes (10)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Measured: Baseline to study completion (up to 24 months)
Duration of Response (DoR)
The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.
Measured: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS) as assessed by investigator
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 24 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Measured: Baseline to study completion (up to 24 months)
Adverse Events (AEs)
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
Measured: Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)
Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions
Measured: Baseline to 45 days after the last dose of study treatment
Tmax
Time to reach the maximum blood concentration
Measured: Baseline to 30 days after the last dose of study treatment
Cmax
Maximum observed blood concentration
Measured: Baseline to 30 days after the last dose of study treatment
AUClast
Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration
Measured: Baseline to 30 days after the last dose of study treatment
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA immunogenicity results.
Measured: Baseline to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start23 Apr 2021
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Lepu Biopharma Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lepu Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Guo, Doctor, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868162
- Sponsor's protocol ID
- MRG003-004
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.
- ClinicalTrials.gov ID
- NCT04868162
- Acronym / sponsor ID
- MRG003-004
- Keywords
- MRG003, Squamous Cell Carcinoma of Head and Neck, EGFR, HX008, PD-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lepu Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 30 Apr 2021 (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.
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.
Detailed description
The study consists of two stages. In Part A, approximately 60 patients will be enrolled to evaluate the safety and preliminarily efficacy of MRG003 at 2.0 and 2.3 mg/kg, to further explore the optimized dose. In Part B, 30 to 50 patients will be enrolled to evaluate the safety and preliminary efficacy of the combination of MRG003 and HX008.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: MRG003, Drug: MRG003+HX008MRG003 monotherapy will be administered for patients enrolled into Part A of this study; MRG003 and HX008 combination will be administered for patients enrolled into Part B of this study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing to sign the ICF and follow the requirements specified in the protocol.
- Expected survival time≥3 months.
- Patients with histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of head and neck.
- Failed prior platinum and/or anti-PD-1 treatment (Part A); failed or intolerant to at least one prior line of standard therapy (platinum-based regimen) (Part B)
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Key exclusion criteria (25 listed)
- History of 4 or more systemic anti-tumor therapies for the recurrent or metastatic squamous cell carcinoma of head and neck.
- ≥Grade 2 peripheral neuropathy
- Prior anti-tumor therapy with MMAE/MMAF ADCs
- BMI≤17
- Expected surgery or any other form of systemic or local anti-tumor therapy.
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 |
|---|---|---|
| MRG003On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or 2.3 mg/kg. | Drug | Experimental Arm |
| MRG003+HX008On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or the recommended dose by SMC; and HX008 will be administered via intravenous infusion at 3.0 mg/kg | Drug | Experimental Arm |
Primary outcome
Objective Response Rate (ORR) by Investigator per RECIST v1.1
Time frame: Baseline to study completion (up to 24 months)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
10 secondary outcomes
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 24 months)
Duration of Response (DoR)
Time frame: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS) as assessed by investigator
Time frame: Baseline to study completion (up to 24 months)
Overall Survival (OS)
Time frame: Baseline to study completion (up to 24 months)
Adverse Events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)
Time frame: Baseline to 45 days after the last dose of study treatment
Tmax
Time frame: Baseline to 30 days after the last dose of study treatment
Cmax
Time frame: Baseline to 30 days after the last dose of study treatment
AUClast
Time frame: Baseline to 30 days after the last dose of study treatment
Incidence of anti-drug antibody (ADA)
Time frame: Baseline to 30 days after the last dose of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruitingPhase 3
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Head and Neck Squamous Cell Carcinoma
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.
Ye Guo, Doctor principal investigator
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG003 and MRG003+HX008 in people with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck, run by Lepu Biopharma Co., Ltd. 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 9 inclusion and 25 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: finished, as of the sponsor's last update on 10 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective Response Rate (ORR) by Investigator per RECIST v1.1 (time frame: Baseline to study completion (up to 24 months)). 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 10 Sep 2026.