LYL273 for Patients With Relapsed or Refractory mCRC

Inclusion Criteria

• Adults > 18 years old
• Clinical and histopathological diagnosis of relapsed or refractory metastatic colorectal cancer
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)
• No surgical options with curative intent
• Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment must have been discontinued for disease progression or intolerance to therapy
• Have at least one extracranial measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 standard

Exclusion Criteria

• Participants with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive tract, urinary bladder, or blood vessel) with LYL273 therapy
• Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT)
• History of or active viral infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
• History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement in the 2-year period leading up to the study enrollment
• No active infectious diseases or comorbid conditions that would interfere with safety or data quality
• Pregnant or breast-feeding women Other protocol defined Inclusion/Exclusion criteria may apply