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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Miracogen Inc.

About this trial

The 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.

Eligibility criteria

Qualifiers

Willing to sign the ICF and follow the requirements specified in the protocol.

Expected survival time≥3 months.

Patients with histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of head and neck.

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)

Disqualifiers

History of 4 or more systemic anti-tumor therapies for the recurrent or metastatic squamous cell carcinoma of head and neck.

≥Grade 2 peripheral neuropathy

Prior anti-tumor therapy with MMAE/MMAF ADCs

BMI≤17

Trial design

Treatments tested in this trial

  • MRG003
  • MRG003+HX008

Treatment groups

116 Participants
are divided into 1 treatment group

Sponsors and collaborators