Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symphogen A/S

Criteria

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