A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

Last updated: January 29, 2026
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

1/2

Condition

Breast Cancer

Treatment

Sacituzumab Govitecan-hziy (SG)

Clinical Study ID

NCT06926920
GS-US-576-7321
2024-519124-25
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Individuals assigned male or female at birth, 18 years of age or older, able tounderstand and give written informed consent.

  • Histologically or cytologically locally confirmed TNBC.

  • Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who arerefractory to or relapsed after at least one prior standard-of-care chemotherapyregimen or systemic therapy given for locally advanced or metastatic disease.

  • Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who havenot received previous systemic therapy for advanced disease.

  • Phase 2: Tumors must be PD-L1 negative, defined as tumor PD-L1 combined positivescore (CPS) < 10 using the PD-L1 immunohistochemistry (IHC) 22C3 assay.Alternatively, individuals with tumor CPS ≥ 10 will be eligible if they received ananti-PD-(L)1 agent (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant settingor 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

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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Sacituzumab Govitecan-hziy (SG)
Phase: 1/2
Study Start date:
April 30, 2025
Estimated Completion Date:
June 30, 2028

Study 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 of SG.

Connect with a study center

  • St. Vincent's Hospital - Kinghorn Cancer Center

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • St. Vincent's Hospital - Kinghorn Cancer Center

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Active - Recruiting

  • Sunshine Coast University Private Hospital

    Birtinya 8348723, Queensland 2152274 4575
    Australia

    Active - Recruiting

  • John Flynn Private Hospital

    Tugun 2145929, Queensland 2152274 4224
    Australia

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Los Angeles Cancer Network (LACN) - Good Sam

    Los Angeles, California 90017
    United States

    Site Not Available

  • Los Angeles Cancer Network (LACN) - Good Sam

    Los Angeles 5368361, California 5332921 90017
    United States

    Active - Recruiting

  • Winship Cancer Institute - Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Winship Cancer Institute - Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • The University of Kansas Hospital

    Westwood 4281639, Kansas 4273857 66205
    United States

    Active - Recruiting

  • Siteman Cancer Center

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • West Cancer Centre

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • West Cancer Centre

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Texas Oncology - DFW

    Dallas 4684888, Texas 4736286 75246
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Active - Recruiting

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