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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
HW221043 Tablets for oral administration at specified doses on scheduled days.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGAdverse 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.
Time frame: 2 years
Dose Limited Toxicity (DLT)
Time frame: 2 years
Maximum Plasma Concentration (Cmax)
Highest Plasma Concentration of HW221043
Time frame: 2 years
Area Under the Concentration-Time Curve (AUC)
Time frame: 2 years
Tmax
Time to Achieve Cmax
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years to 3 years
Progression-Free Survival (PFS)
Time frame: 2 years to 3 years
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