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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06926920Sponsor: Gilead SciencesLast updated: 2026-01-30

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).

Detailed 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.

Arms & interventions

  • DrugSacituzumab Govitecan-hziy (SG)

    Administered intravenously

Outcome measures

Primary

  • 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)

    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

    Time frame: Up to 9 months

  • Phase 2: Progression-Free Survival (PFS)

    PFS is defined as the time from the date of the first SG dose until the date of progressive disease (PD) as assessed by the investigator according to RECIST Version 1.1, or death from any cause, whichever occurs first.

    Time frame: Up to 9 months

Secondary

  • Phases 1 and 2: Serum Concentrations of SG

    Time frame: Up to End of Treatment (3 years)

  • Phase 1 and 2: Percentage of Participants who Develop Antidrug Antibodies (ADAs) Against SG

    Time frame: First dose up to 30 days post last dose (Up to 3 years).

  • Phase 2: Duration of Response (DOR)

    Time frame: First dose up to 30 days post last dose (Up to 3 years).

  • Phase 2: Disease Control Rate (DCR)

    Time frame: Up to 9 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 (9)

Los Angeles Cancer Network (LACN) - Good Sam

Los Angeles, California, 90017

Recruiting

Winship Cancer Institute - Emory University

Atlanta, Georgia, 30322

Recruiting

The University of Kansas Hospital

Westwood, Kansas, 66205

Recruiting

Siteman Cancer Center

St Louis, Missouri, 63110

Recruiting

West Cancer Centre

Germantown, Tennessee, 38138

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203

Recruiting

Texas Oncology - DFW

Dallas, Texas, 75246

Recruiting

Virginia Oncology Associates

Norfolk, Virginia, 23502

Recruiting