To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
ECOG performance status of 0 to 1.
Life expectancy of more than 3 months.
At least one measurable lesion exists.(RECIST 1.1)
Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
Known active infection within 2 weeks prior to baseline.
Subjects with third space fluid that can not be controled.
Subjects with uncontrolled or severe cardiovascular disease.
Single group
SPH5030 tablets
DrugSPH5030 tablets orally once or twice daily.
Dose-limiting toxicity (DLT)
Measurement of DLT of SPH5030 in all subjects
Maximum tolerated dose（MTD）
Measurement of MTD of SPH5030 in all subjects
Number of patients with adverse events
Adverse event type, incidence, duration, correlation with study drug
Maximum serum concentration (Cmax) of SPH 5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time of maximum serum concentration (Tmax) SPH 5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
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