The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Administered as a slow intravenous (IV) infusion.
UCLA Jonsson Comprehensive Cancer Center
Santa Monica, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Helen F. Graham Cancer Center-Christiana Care
Newark, Delaware, United States
IUHealth Goshen Center for Cancer Care
Goshen, Indiana, United States
Percentage of Participants With Adverse Events and Serious Adverse Events (SAEs)
Time frame: From first dose date up to approximately 2 years after the last dose or until disease progression
Percentage of Participants With Laboratory Abnormalities
Time frame: From first dose date up to approximately 2 years after the last dose or until disease progression
Duration of Response
Duration of response (DOR) is defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression (PD) or death from any cause.
Time frame: From first documentation of PR or CR to the earlier of the first documentation of PD or death from any cause (Up to approximately 2 years after the last dose or until disease progression)
Progression-free Survival
Progression free survival (PFS) is defined as the interval from the start of study drug treatment to the earlier of the first documentation of disease progression or death from any cause.
Time frame: From first dose date up to 12 weeks post treatment (Up to approximately 2 years after the last dose or until disease progression)
Time to Progression
Time to progression is defined as the interval from the first dose of treatment to the first documentation of disease progression (PD).
Time frame: From first dose of study treatment up to PD (Up to approximately 2 years after the last dose or until disease progression)
Overall Survival
Overall survival is defined as the time from start of study drug treatment to death from any cause.
Time frame: From first dose date up to approximately 2 years
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The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Fox Chase
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Time-to-treatment Failure
Time to treatment failure (TTF) is defined as the interval from the start of treatment to the earlier of the first documentation of disease progression or death due to any cause, the permanent cessation of LG therapy due to all reasons except progressive disease, participant died or lost to follow up.
Time frame: From first dose date up to 8 treatment cycles (each cycle = 21 days) (Up to approximately 24 weeks)
Change from Baseline in Carcinoembryonic Antigen (CEA) Serum Levels
Time frame: From first dose date up to approximately 2 years after the last dose or until disease progression