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.
Single group
HW221043 Tablets
DrugHW221043 Tablets for oral administration at specified doses on scheduled days.
Adverse Events (AE) or Serious Adverse Events (SAE)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE 6.0.
Dose Limited Toxicity (DLT)
Maximum Plasma Concentration (Cmax)
Highest Plasma Concentration of HW221043
Area Under the Concentration-Time Curve (AUC)
Tmax
Time to Achieve Cmax
Objective Response Rate (ORR)
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