The Top GI Cancer News of 2025
Leronlimab Gets FDA Nod for Phase 2 Microsatellite-Stable CRC Trial
The FDA cleared the start of a phase 2 clinical trial to evaluate leronlimab, an investigational monoclonal antibody that targets CCR5 markers on tumor cells, in patients with relapsed/refractory microsatellite-stable CRC.
This open-label, randomized, 2-arm study will assess the drug's safety and efficacy when combined with standard treatments, trifluridine and tipiracil (TAS-102), and bevacizumab (Avastin). The trial aims to enroll approximately 60 patients who are positive for CCR5 expression. The primary end points include overall response rate, with secondary end points focusing on overall survival and safety. The estimated primary completion date for this study is June 2028.
https://www.targetedonc.com/view/the-top-gi-c...ws-of-2025