Phase I/Ib clinical trial of Sabatolimab, an Anti-TIM-3 Antibody, Alone and in Combination With Spartalizumab, an Anti-PD-1 Antibody, in Advanced Solid Tumors

Purpose: Sabatolimab (MBG453) and spartalizumab are monoclonal antibodies that bind T-cell immunoglobulin domain and mucin domain-3 (TIM-3) and programed death-1 (PD-1), respectively. This phase I/II study evaluated the safety and efficacy of sabatolimab, with or without spartalizumab, in patients with advanced solid tumors. Experimental design: Primary objectives of the phase I/Ib part were to characterize the safety and estimate recommended doses for future studies (RP2Ds). Dose escalation was guided by a Bayesian (hierarchical) logistic regression model. Sabatolimab was administered intrave... Mehr ...