Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tovecimig · 1 trial · 2 indications
Defined as the proportion of patients who have a partial response (PR) or complete response (CR) per RECIST 1.1. CR is defined as disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen) | EXPERIMENTAL | Treatment will be administered in 28-day cycles. On Day 1 and 15 of each cycle, patients will receive Tovecimig followed by the FOLFIRI regimen. |
| Name | Type | Description |
|---|---|---|
| Tovecimig | BIOLOGICAL | 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. |
| Irinotecan | DRUG | 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. |
| Leucovorin | DRUG | 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. |
| 5-Fluorouracil (5-FU) | DRUG | 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. |
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. bow...
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