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
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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