drugset / Trial / NCT06699836

The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)

NCT06699836 ↗

Phase 2 Active not recruiting 66 enrolled CytoDyn, Inc. Syneos Health · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with MSS, mCRC who have progressed on prior treatment before participating in the study. The main questions this study aims to answer are: 1. Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in persons with MSS, mCRC who have progressed on prior treatment before participating in the study. 2. Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.

Timeline

Start
2025-06-16
Primary completion
2028-01
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Leronlimab Monoclonal antibody 350 mg —
Subject Leronlimab Monoclonal antibody 700 mg —

Indications