A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.

Prior treatment

• 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;

Other illness

• 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;
  • 5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.

• 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；
• Expected survival ≥ 3 months;
• No serious abnormalities in hematopoietic function, liver or kidney function;
• Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
• Fully informed subjects who voluntarily sign the ICF.