LYL273 for Patients With Relapsed or Refractory mCRC
ConditionColorectal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLyell Immunopharma, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
LYL273
DrugSingle infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)
Treatment groups
155 Participants
are divided into 1 treatment groupGroup A: LYL273Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1: Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation study
Time frame
Infusion (Day 0) to Day 282
Phase 1: Maximum tolerable dose (MTD) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study
Time frame
Infusion (Day 0) to Day 283
Phase 1: Recommended Phase 2 dose (RP2D) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study
Time frame
Infusion (Day 0) to Day 284
Phase 2: Estimate the efficacy of LYL273, as measured by overall response rate (ORR) based on Independent Review Committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 criteria
Time frame
Baseline to Month 18Secondary outcomes
1
Phase 1 and 2: Evaluate the efficacy of LYL273
ORR based on investigator assessment per RECIST Version 1.1 criteria
Time frame
Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months2
Phase 1 and 2: Evaluate the efficacy of LYL273
Duration of response (DOR) based on Investigator assessment per RECIST Version 1.1 criteria.
Time frame
Date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria until the date of disease progression or recurrence or date of death whichever comes first3
Phase 1 and 2: Evaluate the efficacy of LYL273
Time to response based on Investigator assessment per RECIST Version 1.1 criteria.
Time frame
Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months4
Phase 2: Evaluate the efficacy of LYL273
Duration of response based on IRC assessment per RECIST Version 1.1 criteria
Time frame
Date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria until the date of disease progression or recurrence or date of death whichever comes firstSponsors and contacts
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Source ClinicalTrials.gov