Washington University School of Medicine
This is an open-label Phase 2 study to evaluate the safety and efficacy of Tovecimig combined with FOLFIRI in patients who have received one prior line of therapy for advanced or metastatic colorectal cancer (CRC).
Inclusion Criteria: * Histologically or cytologically confirmed CRC. * Patient must have undergone resection of his/her primary tumor either as part of treatment for early stage disease with subsequent metastatic progression or due to a tumor related complication in the metastatic setting (e.g. bowel obstruction). * Measurable disease per RECIST 1.1. * Patient must have advanced or metastatic disease, and have progressed on one line of standard of care therapy in the advanced/metastatic setting * At least 18 years of age. * ECOG performance status ≤ 2 * Adequate bone marrow and organ function…
Tovecimig is provided in 10 mg/kg dose intravenously over the course of 60 minutes on Day 1 and Day 15 of a 28-day cycle.
Standard of care irinotecan will be given at a dose of 180 mg/m\^2 intravenously on Day 1 and Day 15 of each 28-day cycle as part of the FOLFIRI treatment regimen.
Standard of care leucovorin will be given at a dose of 400 mg/m\^2 intravenously on Day 1 and Day 15 of each 28-day cycle as part of the FOLFIRI treatment regimen.
Standard of care 5-FU will be given at a dose of 2400 mg/m\^2 in continuous infusion over 46 hours on Days 1-2 and Days 15-16 of each 28-day cycle as part of the FOLFIRI treatment regimen.
Arctuva estimate
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