A Phase Ib, Open Lable, Clinical Trial of JAB-21822 Combined With Second Line Chemotherapy for Metastatic Colorectal Cancer With KRAS G12C Mutation
KRAS is a common genetic mutation in tumors, and CRC is one of the tumors with a high KRAS mutation rate. The anti-tumor activity of KRAS G12C inhibitors combined with anti-EGFR anti-bodies have been proven in patients with advanced colorectal cancer, and one of them was approved for patients who have previously received standard treatment. However, Chinese patients still do not have access to these drugs. This study is to determine the efficacy and safety of KRAS G12C inhibitor JAB-21822 in combination with the second-line standard chemotherapy in advanced colorectal cancer failed to standard therapy in Chinese population.
• Histologically (or cytologically) confirmed, unresectable metastatic colorectal cancer.
• KRAS G12C mutation.
• At least one measurable disease per RECIST v1.1; assessed within 28 days before first dose.
• Subject have withdrawn from the first-line chemotherapy due to disease progression or unacceptable toxicity; if first-line chemotherapy and maintenance therapy were received, disease progression must within three months; first-line chemotherapy regimens do not limit the use of antiangiogenic agents.
• Adequate bone marrow, liver and renal function.
• ECOG performance status 0-1.
• Informed consent has been signed.