Loading clinical trials...
Loading clinical trials...
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States
The University of Kansas Hospital
Westwood, Kansas, United States
Siteman Cancer Center
St Louis, Missouri, United States
West Cancer Centre
Germantown, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Texas Oncology - DFW
Dallas, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
St. Vincent's Hospital - Kinghorn Cancer Center
Darlinghurst, New South Wales, Australia
Start Date
April 30, 2025
Primary Completion Date
June 1, 2028
Completion Date
June 1, 2028
Last Updated
January 30, 2026
100
ESTIMATED participants
Sacituzumab Govitecan-hziy (SG)
DRUG
Gilead Clinical Study Information Center
CONTACT
1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.comLead Sponsor
Gilead Sciences
NCT06649331
NCT06134375
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04585750