A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART in Subjects with Relapsed or Refractory Metastatic Colorectal Cancer (CARAPIA-1)
Trial Description
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.
Eligibility Requirements
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