Recruiting
Phase 1
Phase 2

Sacituzumab Govitecan

Sponsor:

Gilead Sciences

Code:

NCT06926920

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab Govitecan-hziy (SG)

Study Details

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 (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).

Conditions

Triple Negative Breast Cancer

Study ID

NCT06926920

Start date

Apr 30, 2025

Status verified date

Jan, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1

Participants will receive SG until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.

experimental: Phase 2: Expansion

Participants will receive SG until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Interventions

Sacituzumab Govitecan-hziy (SG)

Administered intravenously

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

Los Angeles Cancer Network (LACN) - Good Sam

Recruiting

Los Angeles, California, United States, 90017

Winship Cancer Institute - Emory University

Recruiting

Atlanta, Georgia, United States, 30322

The University of Kansas Hospital

Recruiting

Westwood, Kansas, United States, 66205

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

West Cancer Centre

Recruiting

Germantown, Tennessee, United States, 38138

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - DFW

Recruiting

Dallas, Texas, United States, 75246

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Gilead Sciences

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-01-30.