RecruitingRecruiting
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
NCT06926920 · Gilead Sciences
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 100 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-30
Estimated completion: 2028-06
Last updated: 2026-01-30
Interventions
Drug: Sacituzumab Govitecan-hziy (SG)
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).)
Sponsor
Gilead Sciences · industry
Contacts & investigators
ContactGilead Clinical Study Information Center · contact · GileadClinicalTrials@gilead.com · 1-833-445-3230 (GILEAD-0)
InvestigatorGilead Study Director · study_director, Gilead Sciences
All locations (16)
Los Angeles Cancer Network (LACN) - Good SamRecruiting
Los Angeles, California, United States
Winship Cancer Institute - Emory UniversityRecruiting
Atlanta, Georgia, United States
The University of Kansas HospitalRecruiting
Westwood, Kansas, United States
Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
West Cancer CentreRecruiting
Germantown, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Tennessee Oncology, PLLCRecruiting
Nashville, Tennessee, United States
Texas Oncology - DFWRecruiting
Dallas, Texas, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
St. Vincent's Hospital - Kinghorn Cancer CenterRecruiting
Darlinghurst, New South Wales, Australia
Sunshine Coast University Private HospitalRecruiting
Birtinya, Queensland, Australia
John Flynn Private HospitalRecruiting
Tugun, Queensland, Australia
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemNot Yet Recruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea