This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation
study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose
(MTD)/Recommended Phase 2 Dose (RP2D) (Part 2). If MTD is not reached in Part 1, RP2D will be
determined after completion of Part 1 considering safety and tolerability, also beyond the
dose limiting toxicity (DLT) period, pharmacokinetic (PK) and pharmacodynamic (PD) results.