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A Study of Sacituzumab Govitecan Given 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).

ClinicalTrials.gov IDNCT06926920

PhasePHASE1, PHASE2

Enrollment100

SponsorGilead Sciences

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Triple Negative Breast Cancer

About this study

Interventions

Drug: Sacituzumab Govitecan-hziy (SG) — Administered intravenously

Primary outcomes

Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) (First dose up to 28 days)
Phase 1 and 2: Percentages of Participants Experiencing Adverse Events (AEs) (First dose up to 30 days post last dose (Up to 3 years))
Phases 1 and 2: Percentages of Participants Experiencing Laboratory Abnormalities (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 (First dose up to 30 days post last dose (Up to 3 years).)
Phases 1 and 2: Objective Response Rate (ORR) (Up to 9 months)
Phase 2: Progression-Free Survival (PFS) (Up to 9 months)

Eligibility information

Key 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. Key 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.

Study locations

Los Angeles Cancer Network (LACN) - Good Sam, Los Angeles, California 90017 United States
Winship Cancer Institute - Emory University, Atlanta, Georgia 30322 United States
The University of Kansas Hospital, Westwood, Kansas 66205 United States
Siteman Cancer Center, St Louis, Missouri 63110 United States
West Cancer Centre, Germantown, Tennessee 38138 United States
SCRI Oncology Partners, Nashville, Tennessee 37203 United States
Tennessee Oncology, PLLC, Nashville, Tennessee 37203 United States
Texas Oncology - DFW, Dallas, Texas 75246 United States
Virginia Oncology Associates, Norfolk, Virginia 23502 United States
St. Vincent's Hospital - Kinghorn Cancer Center, Darlinghurst, New South Wales 2010 Australia

Showing 10 of 16 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.