A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
NCT ID: NCT06926920
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2025-04-30
2028-06-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1
Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Phase 2: Expansion
Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.
Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Interventions
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Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
John Flynn Private Hospital
Tugun, Queensland, Australia
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2024-519124-25
Identifier Type: OTHER
Identifier Source: secondary_id
2024-519124-25
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-576-7321
Identifier Type: -
Identifier Source: org_study_id
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