The study includes a Dose-escalation Part and a Dose Expansion Part. The aim of the Dose-escalation Part is to estimate the MTD (if possible), identify the DLT (if possible) and the RP2D for PLB1004. The Dose Expansion Part is to further assess the clinical efficacy and safety of PLB1004.
This is a phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PLB1004, and to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D).