This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HW221043 tablets in participants with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).
Men or women ≥18 years old.
Histologically and/or cytologically confirmed recurrent or metastatic advanced solid tumors.
Absence of available standard therapy, failure of standard therapy, or ineligibility for standard therapy.
Survival expectation is ≥12 weeks.
Allergic to HW221043 Tablet or its components.
Has a treatment history of KIF18A inhibitor.
Known presence of a recognizable hypermutated phenotype.
Prior receipt of any unapproved investigational drug or therapy within 28 days before first dose.