This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors.
Age of 18 years or older, applicable to both males and females.
Patients with histologically and/or cytologically confirmed recurrent and/or metastatic advanced solid tumors, mainly covering non - small cell lung cancer, colorectal cancer, pancreatic cancer, cholangiocarcinoma, and other cancer types that investigators believe may bring benefits. The selection of cancer types in the dose - expansion phase will be decided based on the data from the dose - escalation phase.
No standard treatment is accessible, standard treatment has failed, or the patient is not suitable for standard treatment.
The expected survival time is ≥ 12 weeks.
Known allergy to the investigational drug, drugs with the same mechanism of action or excipients.
Prior treatment with drugs targeting the same molecular target.
Use of other investigational drugs within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).
Receipt of surgery, chemotherapy, radiotherapy, targeted therapy, endocrine therapy, biological therapy, immunotherapy, anti - tumor herbal medicine, or other anti - cancer treatments within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).
Sequential
HW071021 Tablets
DrugAdministered orally at pre-specified doses once or twice daily.
Incidence of Treatment-Emergent Adverse Events
Assessed by CTCAE v5.0
Pharmacokinetic Parameter：Maximum Plasma Concentration (Cmax）(Phase 1 only)
Pharmacokinetic Parameter：Area Under the Curve from Time 0 to the Last Quantifiable Data Point (AUC0-t）(Phase 1 only)
Pharmacokinetic Parameter：Area Under the Curve Over a Dosing Interval (AUCss,0-tau）(Phase 1 only)
Pharmacokinetic Parameter：Trough Concentration (Ctrough）
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