A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer
This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.
• Age 18 years old and above, male or female;
• Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;
• At least one measurable lesion;
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;
• A minimum life expectancy of \>3 months;
• Adequate bone marrow reserve, hepatic, renal, and coagulation function;
• Other inclusion criteria apply for participating in the Study. -