Status:
RECRUITING
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Lead Sponsor:
Gilead Sciences
Conditions:
Triple Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 (TNB...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06926920
Start Date
April 30 2025
End Date
June 1 2028
Last Update
October 16 2025
Active Locations (15)
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1
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California, United States, 90017
2
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States, 30322
3
Siteman Cancer Center
St Louis, Missouri, United States, 63110
4
West Cancer Centre
Germantown, Tennessee, United States, 38138