Clinical Data
Results:
Enrolment began in December, 2015. As of October 11, 2016, 13 patients with R/M SCCHN were enrolled at dose levels 0.4, 1, 2 and 4 mg/kg. Median age was 60 years (range: 40-74); 92% were male; PS was 0 or 1; all patients had received prior systemic therapy (1 prior line in 1 patient and > 2
lines in 12 patients) for R/M SCCHN including platinum based chemotherapy (100% of the patients) and cetuximab (85%). There were no DLTs, infusion related reactions, immune related disorders or deaths related to treatment. No discontinuation attributable to treatment-related adverse events and no treatment-related grade 3 and 4 adverse events were reported, except fatigue (grade 3) in one patient. Updated data including pharmacodynamics and pharmacokinetics on the full dose escalation part will be presented.