A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
• Intervention / Treatment: Drug: MRG003; Drug: MRG003+HX008

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 Type: Interventional
• Enrollment (Estimated): 116
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Program Director; Phone Number: 86-21-61637960; Email: clinicaltrials@miracogen.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200123
      • Recruiting
      • Shanghai East Hospital
      • Contact: Ye Guo, Doctor; Phone Number: 22132 86-21-38804518; Email: pattrickguo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; 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.	Drug: MRG003; 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.; Drug: MRG003+HX008; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to study completion (up to 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 30 days after the last dose of study treatment
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.	Baseline to study completion (up to 24 months)
Incidence of anti-drug antibody (ADA)	The proportion of patients with positive ADA immunogenicity results.	Baseline to 30 days after the last dose of study treatment
Overall Survival (OS)	OS is defined as the duration from the start of treatment to death of any cause.	Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)	DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.	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.	Baseline to study completion (up to 24 months)
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	Baseline to 45 days after the last dose of study treatment
Tmax	Time to reach the maximum blood concentration	Baseline to 30 days after the last dose of study treatment
Cmax	Maximum observed blood concentration	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	Baseline to 30 days after the last dose of study treatment

Collaborators and Investigators

• Sponsor: Shanghai Miracogen Inc.
• Investigators: Principal Investigator: Ye Guo, Doctor, Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: EGFR; PD-1; Squamous Cell Carcinoma of Head and Neck; MRG003; HX008
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Recurrence; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: MRG003-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No