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).
Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
Histologically or cytologically locally confirmed TNBC.
Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease.
Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.
Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
Sequential
Sacituzumab Govitecan-hziy (SG)
DrugAdministered intravenously
Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs)
Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities
Phases 1 and 2: Percentages of Participants Experiencing AEs Leading to Dose Reductions, Dose Interruptions, and Treatment Discontinuations
Phases 1 and 2: Serum Concentrations of SG
Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG
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.
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.
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