CP-START 001

For Phase 1, the primary objective is to define the safety profile, tolerability, and dose-limiting toxicities (DLT), and to determine the recommended dose for Phase 2 (RP2D) of STAR0602. For Phase 2, the primary objective is to further investigate the antitumor activity of STAR0602 in locally advanced or metastatic unresectable solid tumors. ;For Phase 1, the secondary objectives are to evaluate the preliminary antitumor activity of STAR0602 in locally advanced or metastatic unresectable solid tumors, and to assess the pharmacokinetic (PK) profile of STAR0602 in serum after single and repeated IV infusions. ;For Phase 2, the secondary objectives are to continue evaluating the antitumor activity of STAR0602, assess the PK profile of STAR0602 in serum after single and repeated IV infusions, and further define the safety and tolerability of STAR0602. Additionally, for both Phase 1 and Phase 2, a secondary objective is to evaluate the formation of anti-drug antibodies (ADA) after the administration of a single IV dose and repeated doses of STAR0602.