To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
HER2 positive or HER2 gene mutation;
Meet the requirements of previous treatment;
ECOG performance status of 0 or 1；
Subjects who have previously received anti-HER2 molecular targeted therapy;
Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;
Single group
SPH5030
DrugSPH5030：Oral, QD, 600mg
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Duration of remission (DOR)
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Overall Survival (OS)
Determination of the overall survival times of all patients
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