NCT05751512

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

A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate MRG003 vs Cetuximab/Methotrexate as Second/Third Line of Treatment in Patient With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai Miracogen Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, open-label, multicenter Phase III study 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. Approximately 180 patients will be enrolled, randomized, and stratified according to the following: Eastern Cooperative Oncology Group Performance Status (ECOG PS, 0 vs 1) and prior treatment with anti-EGFR mAb (yes vs no). For patients in the control group, cetuximab will be selected as comparator if no prior treatment with anti-EGFR mAb; otherwise, methotrexate will be selected. After signing the informed consent and screened per inclusion/exclusion criteria, eligible patients will be randomized at a ratio of 1 : 1 and treated with MRG003 (2.3 mg/kg, IV, d1, Q3W) or cetuximab (400 mg/m2 for the first week and 250 mg/m2 for subsequent weeks, QW) / methotrexate (40 mg/m2, IV, QW) until disease progression, death, intolerable toxicity, withdrawal of consent, initiation of a new anti-tumor therapy, or other reasons leading to treatment discontinuation as specified by protocol.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	MRG003	Administered intravenously
DRUG	Cetuximab injection	Administered intravenously
DRUG	Methotrexate Injection	Administered intravenously

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-08-01
• Completion: 2025-12-01
• First posted: 2023-03-02
• Last updated: 2023-03-02

Locations

1 site across 1 country: China