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LYL273 for Patients With Relapsed or Refractory mCRC

RecruitingPhase 1/2

A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of LYL273 in Patients With Relapsed or Refractory Metastatic Colorectal Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the 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.

What is being tested

Sponsor: Lyell Immunopharma, Inc. · Participants: 155 · Started: Aug 1, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05319314

Locations in the U.S.

CaliforniaCity of Hope Comprehensive Cancer Center, Duarte
University of California San Francisco Medical Center, San Francisco
ColoradoUniversity of Colorado Hospital - Anschutz Cancer Pavilion, Aurora
MassachusettsDana-Farber Cancer Institute, Boston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.