Recruiting
Phase 1 / Phase 2
LYL273 for Patients With Relapsed or Refractory mCRC
About this study
This is a Phase 1/2 open-label, multicenter study evaluating the safety and efficacy of LYL273 in participants with relapsed or refractory metastatic colorectal cancer.
- Condition
- Colorectal Cancer
- Tested
- LYL273
- Sponsor
- Lyell Immunopharma, Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Study condition: Colorectal Cancer
- 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 7
- 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
Where
4 sites, 4 recruiting
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Potential match only. Final eligibility is determined by the study team.