Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

An Open-label, Single Arm, Phase II Trial to Investigate the Safety and Efficacy of Sym004 in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Who Have Failed Anti-EGFR Monoclonal Antibody-based Therapy

The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.

Symphogen was the sponsor for planning/conducting and reporting results for this trial.

Inclusion Criteria:

• Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx

• Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation

• Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:

  • Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
  • Documented disease progression (verified by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb

• Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies

• Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

• More than 2 lines of prior chemotherapy in the palliative setting
• Expected survival <12 weeks
• Subjects with known brain metastases
• Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
• Anti-EGFR mAbs within 14 days prior to Visit 2
• Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from effects of major surgery
• Other protocol-defined exclusion criteria could apply