A Phase 2 Clinical Trial of Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer
Washington University School of Medicine
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalTovecimig
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.
- DrugIrinotecan
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.
- DrugLeucovorin
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.
- Drug5-Fluorouracil (5-FU)
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.
Location
- Washington University School of MedicineSt Louis, Missouri