LYL273 for Patients With Relapsed or Refractory mCRC
Recruiting
Phase 1Phase 2Interventional Study
Colorectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
155 (estimated)
Sponsor
Lyell Immunopharma, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced colorectal cancer that has come back or has not responded to previous treatments. Participants will receive a new treatment called LYL273 and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have been diagnosed with metastatic colorectal cancer.
I have a performance status of 0 or 1.
I have limited liver disease.
I have no surgical options to cure my cancer.
I have received specific prior chemotherapy treatments.
I have at least one measurable tumor outside my brain.
You may not be able to join if
I have tumors in a location that could cause organ perforation.
I have active cancer in my brain.
I have a history of viral infections like HIV or hepatitis.
I have had a CNS disorder in the last 2 years.
I have active infections or other health conditions affecting safety.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
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Status
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 surg…
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
Contacts
No contact information available.
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