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OncoMatch/Clinical Trials/NCT04868162

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

Is NCT04868162 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including MRG003 and MRG003+HX008 for recurrent or metastatic squamous cell carcinoma of head and neck.

Phase 2RecruitingShanghai Miracogen Inc.NCT04868162Data as of May 2026

Treatment: MRG003 · MRG003+HX008The 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.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 3 prior lines

Must have received: platinum-based chemotherapy — recurrent or metastatic

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)

Cannot have received: MMAE/MMAF antibody-drug conjugate

Prior anti-tumor therapy with MMAE/MMAF ADCs

Lab requirements

Blood counts

Organ functions and coagulation function must meet the basic requirements.

Kidney function

Organ functions and coagulation function must meet the basic requirements.

Liver function

Organ functions and coagulation function must meet the basic requirements.

Organ functions and coagulation function must meet the basic requirements.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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