About this trial
To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SPH5030