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

Last updated: May 7, 2025
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

  • Los Angeles Cancer Network (LACN) - Good Sam

    Los Angeles, California 90017
    United States

    Active - Recruiting

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