Phase I/II, multicenter, open-label study of intratumoral/intralesional administration of the retinoic acid–inducible gene I (RIG-I) activator MK-4621 in patients with advanced or recurrent tumors

Abstract

From page 4, Abstract 504P, RA Moss et al Materials and methods: This study consisted of two phases: a Phase Ia dose- escalation and expansion at the recommended Phase2 dose (RP2D; 15mg/kg IV Q3W); and a Phase Ib testing MetMAb (10mg/kg or 15mg/kg IV Q3W) in combination with bevacizumab (15mg/kg Q3W). Serum was collected for evaluation of pharmacodynamic biomarkers, including IL8 and HGF. Results: 34 patients have been treated in Phase Ia and 9 patients in Phase Ib. MetMAb has a half-life of approximately 11 days, and there are no apparent PK interactions with bevacizumab. MetMAb was generally well tolerated. The most frequent treatment- related adverse events included: fatigue, peripheral edema and hypoalbuminemia. In the Ib section, no Gr3-5 drug-related toxicities were observed; a Gr1, and dose-limiting toxicity of hemoptysis was observed in cohort 2 in a patient who had central-necrosis of pulmonary metastases. A patient with gastric carcinoma achieved a complete response after 4 cycles of MetMAb; this patient came off study after 10 cycles and continues to have a complete response as of 560 days following the last dose.