LAST UPDATED
January 30, 2026
Clinicaltrials.gov ID
CTSID
CTSID
OVERVIEW
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
PROTOCOL 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).
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Triple Negative Breast Cancer
Gender
N/A
Date
April 2025 - June 2028
Study Type
Interventional
Study Phase
Phase 1, Phase 2
Product
Sacituzumab Govitecan-hziy (SG)
Eligibility information
Inclusion criteria
- 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.
- Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positive score (CPS) < 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay. Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received an anti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting or if they cannot be treated with an anti-PD-(L)1 agent. due to a comorbidity.
- Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.
- During Phase 1 safety run-in, individuals must be UGT1A1 wild-type.
- After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate hematologic counts within 2 weeks prior to enrollment.
- Adequate hepatic and renal function.
Exclusion criteria
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria will apply.
Locations
Locations (16)
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California, United States, 90017
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States, 30322
The University of Kansas Hospital
Westwood, Kansas, United States, 66205
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
St. Vincent's Hospital - Kinghorn Cancer Center
Darlinghurst, New South Wales, Australia, 2010
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia, 4575
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
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