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

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 trea

Trial Details

NCT ID
NCT06699836
Phase
PHASE2
Sponsor
CytoDyn, Inc.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • 350 mg leronlimab
  • 700 mg leronlimab
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • San Francisco, California, United States|37.77493,-122.41942
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Louisville, Kentucky, United States|38.25424,-85.75941
  • Omaha, Nebraska, United States|41.25626,-95.94043

Key Eligibility Criteria

  • Male or female subjects age ≥ 18 years with a history of treated colorectal cancer with unresectable metastases of the primary colorectal cancer to…
  • If HIV-1 positive, viral load must be \< 50 copies/ml and participant must be on stable ART for at least 3 months.
  • Adult patients with metastatic colorectal cancer (mCRC) received and progressed, or are intolerant, of at least two prior standard of care treatmen…
  • Histologically confirmed for microsatellite stable MSS colorectal cancer by PCR, Immunohistochemistry (IHC) or Next-generation sequencing (NGS).

For full eligibility, visit ClinicalTrials.gov.

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