The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC). The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).
Phase 1 of this study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and efficacy of SG. Phase 2 expansion of this study will further evaluate the safety, efficacy, and PK of SG.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Administered intravenously
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California, United States
RECRUITINGWinship Cancer Institute - Emory University
Atlanta, Georgia, United States
RECRUITINGThe University of Kansas Hospital
Westwood, Kansas, United States
RECRUITINGSiteman Cancer Center
St Louis, Missouri, United States
RECRUITINGWest Cancer Centre
Germantown, Tennessee, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGTennessee Oncology, PLLC
Nashville, Tennessee, United States
RECRUITINGTexas Oncology - DFW
Dallas, Texas, United States
RECRUITINGVirginia Oncology Associates
Norfolk, Virginia, United States
RECRUITINGSt. Vincent's Hospital - Kinghorn Cancer Center
Darlinghurst, New South Wales, Australia
RECRUITING...and 6 more locations
Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: First dose up to 28 days
Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)
Time frame: First dose up to 30 days post last dose (Up to 3 years)
Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment Discontinuations
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phases 1 and 2: Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame: Up to 9 months
Phase 2: Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first SG dose until the date of progressive disease (PD) as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.
Time frame: Up to 9 months
Phases 1 and 2: Serum Concentrations of SG
Time frame: Up to End of Treatment (3 years)
Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phase 2: Duration of Response (DOR)
DOR is defined as the time from the first documentation of CR or PR to the first documentation of PD as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phase 2: Disease Control Rate (DCR)
DCR is defined as the proportion of participants who achieve CR, PR, or stable disease as assessed by the investigator according to RECIST Version 1.1.
Time frame: Up to 9 months
Gilead Clinical Study Information Center
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