LifeTracDx blood test will evaluate PD-L1 expression changes as exploratory biomarker in trial combining leronlimab with standard therapies.
Creatv Bio has partnered with CytoDyn Inc to provide its LifeTracDx liquid biopsy test as an exploratory biomarker in a Phase 2 study evaluating leronlimab combined with TAS-102 and Bevacizumab in patients with relapsed/refractory metastatic colorectal cancer (mCRC).
The ongoing Phase 2 study is enrolling 60 participants who will undergo LifeTracDx blood testing at multiple time points throughout the trial. The test will evaluate numeric increases in PD-L1 expression across the patient population as part of the study protocol.
The study’s primary endpoint is objective response rate, defined as the proportion of patients achieving confirmed complete or partial response per RECIST v1.1. The trial evaluates leronlimab’s efficacy in combination with trifluridine and tipiracil plus bevacizumab in patients with CCR5-positive, refractory, microsatellite-stable mCRC over a 12-month treatment period.
Technology Uses Multiple Cell Types for Monitoring
LifeTracDx uses both circulating tumor cells (CTCs) and Cancer Associated Macrophage-Like (CAML) cells as markers for real-time monitoring of tumor response to treatment. CAML cells are macrophages that engulf tumor cells, and the technology provides pharmacokinetic changes of both CCR5 and PD-L1 from the tumor microenvironment.
Previous studies showed leronlimab induced PD-L1 expression on CTCs and CAMLS in 88% of metastatic breast cancer patients treated at doses above 525 mg per week. This supports the proposed ability of CCR5 blockade to convert “cold” tumors into “hot,” PD-L1-positive tumors, according to a release from Creatv Bio.
Changes observed in circulating atypical CAMLs further support leronlimab’s role in remodeling the tumor immune microenvironment and enhancing responsiveness to checkpoint blockade.
Creatv Bio has demonstrated that monitoring PD-L1 expressions using the LifeTracDx blood test at baseline, followed by sequential sampling after therapy induction, may identify patients who have upregulated PD-L1 expression in their tumors.
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