The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered intravenously
Pacific Shores Medical Group
Long Beach, California, United States
SUSPENDEDChristiana Care Health Services
Newark, Delaware, United States
Percentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEs
Time frame: First dose date up to Day 38
Percentage of Participants Experiencing Any Dose Limiting Toxicities (DLTs)
Time frame: Up to Day 22 (for participants receiving SG on Day 1); Up to Day 28 (for participants receiving SG on Day 8)
Percentage of Participants Experiencing Any Clinically Significant Laboratory Abnormalities
Time frame: First dose date up to Day 38
Pharmacokinetic (PK) Parameter: Cmax of Free SN-38 and Sacituzumab Govitecan-hziy
Cmax will be determined for 2 analytes: Free SN-38 and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. Cmax is defined as the maximum observed concentration obtained directly from the observed concentration-time data.
Time frame: Days 1 and 8
PK Parameter: AUC 0-168 of Free SN-38 and Sacituzumab Govitecan-hziy
AUC 0-168 will be determined for 2 analytes: Free SN-38 and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC0-168 is defined as area under the serum concentration-time curve from time 0 to 168 hours.
Time frame: Days 1 and 8
Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy Antibodies
Time frame: Day 1 (Predose) and Day 22
Gilead Clinical Study Information Center
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University of Maryland
Baltimore, Maryland, United States
RECRUITINGNEXT Austin
Austin, Texas, United States
WITHDRAWNOncology Consultants, P.A.
Houston, Texas, United States
RECRUITINGThe University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
RECRUITINGTexas Liver Institute
San Antonio, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGInstitut Bergonie Medical Oncology
Bordeaux, France
RECRUITINGCentre Leon Berard
Lyon, France
RECRUITING...and 3 more locations