 Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities DLT. PK: Peak Plasma Concentration Cmax, Area under the plasma concentration versus time curve AUC, Time of Maximum concentration observed Tmax. Efficacy: Overall Response Rate ORR, Progression Free Survival PFS, Overall Survival OS and Duration of Response. 