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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

MRG003MRG003+HX008

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT04868162 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior MMAE/MMAF antibody-drug conjugate disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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