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NCT06926920PHASE1, PHASE2Recruiting

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

Gilead Sciences

Start Date

4/30/2025

Completion Date

6/1/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Sacituzumab Govitecan-hziy (SG)

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Conditions

Triple Negative Breast Cancer

Locations

Los Angeles Cancer Network (LACN) - Good Sam

Los Angeles, California 90017

United States

Winship Cancer Institute - Emory University

Atlanta, Georgia 30322

United States

The University of Kansas Hospital

Westwood, Kansas 66205

United States

Siteman Cancer Center

St Louis, Missouri 63110

United States

West Cancer Centre

Germantown, Tennessee 38138

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology, PLLC

Nashville, Tennessee 37203

United States

Texas Oncology - DFW

Dallas, Texas 75246

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

St. Vincent's Hospital - Kinghorn Cancer Center

Darlinghurst, New South Wales 2010

Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland 4575

Australia

John Flynn Private Hospital

Tugun, Queensland 4224

Australia

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea