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