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
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 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 CT scan or MRI according to RECIST
(1.1) during or within 12 weeks following the last administration of anti-EGFR
mAb
- Accessible tumor for biopsy and patient acceptance of repeat tumor biopsies
Exclusion Criteria:
- More than 2 lines of prior chemotherapy in the palliative setting
- Expected survival <12 weeks
- Patients 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 patients must have recovered from
effects of major surgery