New treatment option for Colorectal Cancer
Official title LYL273 for Patients With Relapsed or Refractory mCRC
ClinicalTrials.gov ID: NCT05319314
What this study is testing
What is LYL273?
LYL273 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- 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
See the full eligibility 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...
- Have at least one extracranial measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 standard
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.