Study Details

PROTOCOL 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).

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Triple Negative Breast Cancer

Gender

N/A

Date

April 2025 - June 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE1, PHASE2

Product

Sacituzumab Govitecan-hziy (SG)

Eligibility Information

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.

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.

Locations

Locations (15)

Los Angeles Cancer Network (LACN) - Good Sam

Los Angeles, California, United States, 90017

Winship Cancer Institute - Emory University

Atlanta, Georgia, United States, 30322

Siteman Cancer Center

St Louis, Missouri, United States, 63110

West Cancer Centre

Germantown, Tennessee, United States, 38138

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

Texas Oncology - DFW

Dallas, Texas, United States, 75246

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

St. Vincent's Hospital - Kinghorn Cancer Center

Darlinghurst, New South Wales, Australia, 2010

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia, 4575

John Flynn Private Hospital

Tugun, Queensland, Australia, 4224

Seoul National University Hospital

Seoul, South Korea, 03080

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Asan Medical Center

Seoul, South Korea, 05505

Samsung Medical Center

Seoul, South Korea, 06351

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

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