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

Inclusion criteria

• ✓. 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.
• ✓. 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 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.
• ✓. Histologically confirmed for microsatellite stable MSS colorectal cancer by PCR, Immunohistochemistry (IHC) or Next-generation sequencing (NGS).
• ✓. Have measurable disease per RECIST 1.1
• ✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• ✓. Expected survival of at least three months.
• ✓. No anti-cancer treatment within the last two weeks or at least 5 half-lives prior to treatment (whichever is shorter), except for palliative radiation therapy from which the patient has recovered from all adverse events.

Exclusion criteria