LYL273 for Patients With Relapsed or Refractory mCRC
Recruiting · NCT05319314 · Interventional (participants receive a specific treatment) · Lead sponsor: Lyell Immunopharma, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
LYL273
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- ther protocol defined Inclusion/Exclusion criteria may apply
Where it is running
4 locations listed across 3 US states.
- City of Hope Comprehensive Cancer Center - Duarte, California, United States
- University of California San Francisco Medical Center - San Francisco, California, United States
- University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora, Colorado, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States