A first-in-human (FIH) study of PF-04518600 (PF-8600) OX40 agonist in adult patients (pts) with select advanced malignancies

Abstract

Methods: A Phase 1, open label, multicenter study is ongoing to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PF-8600 in pts with advanced melanoma, head and neck squamous cell, renal cell, or hepatocellular carcinoma. PF-8600 was administered intravenously at increasing doses (0.01 – 3 mg/kg) every 2 weeks until disease progression or unacceptable toxicity. Additional biomarker cohorts (opened at each dose level except 0.01 mg/kg) enrolled pts who consented to baseline and on-treatment tumor biopsies for immune profiling by immunohistochemistry and RNAseq.