NCT06699836 The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER)
| NCT ID | NCT06699836 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | CytoDyn, Inc. |
| Condition | Metastatic Colorectal Cancer (mCRC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-16 |
| Primary Completion | 2028-01 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects age ≥ 18 years with a history of treated colorectal cancer with unresectable metastases of the primary colorectal cancer to other organs. 2. If HIV-1 positive, viral load must be \< 50 copies/ml and participant must be on stable ART for at least 3 months. 3. Adult patients with metastatic colorectal cancer (mCRC) received and progressed, or are intolerant, of at least two prior standard of care treatment regimes, which may have included fluoropyrimidine-, oxaliplatin-, or irinotecan chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. 4. Histologically confirmed for microsatellite stable MSS colorectal cancer by PCR, Immunohistochemistry (IHC) or Next-generation sequencing (NGS). 5. Have measurable disease per RECIST 1.1 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Expected survival of at least three months. 8. No anti-cancer treatment within the
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