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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Washington University School of Medicine
St Louis, Missouri, United States
Overall Response Rate (ORR)
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.
Time frame: Start of treatment to completion of treatment (estimated time up to 12 months)
Progression-Free Survival (PFS)
PFS is defined as the time from date of start of treatment to the date of disease progression or death, whichever occurs first. Alive patients without disease progression are censored at the last follow-up otherwise. PFS will be assessed using the Kaplan-Meier method. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: Start of treatment to date of progression or death whichever is earlier (estimated time to be up to 36 months)
Overall Survival (OS)
OS is defined as the time from date of treatment start to the date of death. Alive patients are censored at the last follow-up otherwise. OS will be assessed using the Kaplan-Meier method.
Time frame: Start of treatment to date of death (estimated time to be up to 36 months)
Number and types of adverse events (AEs)
As assessed by CTCAE v6.0.
Time frame: Start of treatment to 30 days after completion of treatment (estimated total time to be 13 months)
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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.
Disease Control Rate (DCR)
DCR is defined as complete response (CR) plus partial response (PR) plus stable disease (SD) as assessed per RECIST v1.1 as best overall response. 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. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Time of best response through completion of follow-up (estimated total time to be up to 36 months)
Change in quality of life as measured by Eastern Cooperative Oncology Group (ECOG) performance status
ECOG performance scale is graded as follows: Grade 0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). Grade 2: In bed \<50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. Grade 3: In bed \>50% of the time. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. Grade 4:100% bedridden. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. Grade 5: Death A lower ECOG performance score indicates a better quality of life.
Time frame: Baseline to end of treatment (total estimated time 12 months)