An Open-Label, Multicenter, Phase I/II Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors
Objective
Phase I: To determine the maximum tolerated dose (MTD) as determined by incidence of dose limiting toxicities (DLT) and/or the RP2D of RP1. To assess the safety and tolerability of RP1 alone and in combination with nivolumab as determined by the incidence of all treatment-emergent adverse events (TEAEs), ≥ Grade 3 TEAEs, serious adverse events (SAEs), and TEAEs requiring withdrawal from investigational product (IP) treatment. Phase II: To assess the safety and tolerability of RP1 in combination with nivolumab as determined by the incidence of all TEAEs, ≥ Grade 3 TEAEs, SAEs, and TEAEs requiring withdrawal from IP treatment To assess the efficacy of RP1 in combination with nivolumab as determined by ORR using RECIST 1.1 criteria
