To evaluate the safety and efficacy of SHR-A1904 in the advanced colorectal cancer after failure of standard therapy
Age 18-75 years, male or female.
Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
Failure of at least second-line standard systemic therapy, and must have received oxaliplatin, irinotecan, and fluoropyrimidine-based chemotherapy. Subjects who have received all three classes of chemotherapeutic agents in first-line therapy may be enrolled after first-line treatment failure. For subjects with dMMR/MSI-H tumors, prior anti-PD-1/PD-L1 antibody therapy must have failed.
At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Known history of hypersensitivity to any component of the investigational product.
Received systemic anti-tumor therapy within 4 weeks before the start of study treatment. If prior anti-tumor therapy was small molecule targeted therapy, the interval between the end of that treatment and the first study treatment should be no less than 5 half-lives of the drug or 7 days, whichever is longer. If prior anti-tumor Chinese patent medicine was received, an interval of no less than 2 weeks between the end of that treatment and the first study treatment is allowed.
Toxicities and/or complications from prior interventions have not recovered to NCI-CTCAE grade ≤1 or to the level specified in the inclusion/exclusion criteria (except for toxicities deemed by the investigator to be safely manageable, such as alopecia, grade ≤2 peripheral neuropathy, etc.).
Currently participating in another clinical study, or the time from first study drug administration to the end of a previous clinical study (last dose) is less than 4 weeks or 5 half-lives of that study drug, whichever is shorter.
Peking University Cancer Hospital & Institute
Lead sponsor
Beijing GoBroad Hospital
Collaborator