Recruiting
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.
What is being tested
MRG003
+ MRG003+HX008
Drug
Who is being recruted
Squamous Cell Carcinoma of Head and Neck+9
+ Carcinoma
+ Carcinoma, Squamous Cell
From 18 to 75 Years
+34 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: April 2021
Summary
Principal SponsorShanghai Miracogen Inc.
Study ContactProgram Director
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: April 23, 2021
Actual date on which the first participant was enrolled.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.
Official TitleAn 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.
Principal SponsorShanghai Miracogen Inc.
Study ContactProgram Director
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
116 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Squamous Cell Carcinoma of Head and NeckCarcinomaCarcinoma, Squamous CellHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPathologic ProcessesRecurrencePathological Conditions, Signs and SymptomsDisease Attributes
Criteria
9 inclusion criteria required to participate
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)
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25 exclusion criteria prevent from participating
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
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalMRG003 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Recruiting
One Study Center