A Study to Evaluate MRG003 vs Cetuximab/Methotrexate in in the Treatment of Patients With RM-SCCHN

NCT05751512 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-03-02

No results posted yet for this study

Summary

The objective of this study is to compare the efficacy and safety of MRG003 versus cetuximab/methotrexate as second/third line of therapy in patients with RM-SCCHN who have previously failed PD-1 (L1) inhibitors and platinum-based therapy.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

MRG003

Administered intravenously

DRUG

Cetuximab injection

Administered intravenously

DRUG

Methotrexate Injection

Administered intravenously

Sponsors & Collaborators

  • Shanghai Miracogen Inc.

    lead INDUSTRY

Principal Investigators

  • Ye Guo, PhD · Shanghai East Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2025-08-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751512 on ClinicalTrials.gov