A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Summary
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).
Detailed description
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.
Arms & interventions
- DrugSacituzumab Govitecan-hziy (SG)
Administered intravenously
Outcome measures
Primary
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
Secondary
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)
Time frame: First dose up to 30 days post last dose (Up to 3 years).
Phase 2: Disease Control Rate (DCR)
Time frame: Up to 9 months
Eligibility criteria
Study locations (9)
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California, 90017
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322
The University of Kansas Hospital
Westwood, Kansas, 66205
Siteman Cancer Center
St Louis, Missouri, 63110
West Cancer Centre
Germantown, Tennessee, 38138
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Texas Oncology - DFW
Dallas, Texas, 75246
Virginia Oncology Associates
Norfolk, Virginia, 23502