RecruitingPhase 1Phase 2NCT06926920

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

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


Sponsor

Gilead Sciences

Enrollment

100 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new dosing schedule for sacituzumab govitecan — a targeted antibody-drug treatment — to find out if a different dose and timing can be just as effective but with fewer side effects in people with advanced triple-negative breast cancer (TNBC). **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer that has spread or cannot be removed surgically - Phase 1: You have received at least one prior chemotherapy for advanced TNBC - Phase 2: You have not received prior treatment for advanced TNBC, AND your tumour's PD-L1 score (CPS) is below 10 (meaning immunotherapy alone is unlikely to be effective) **You may NOT be eligible if...** - You have untreated or symptomatic brain metastases - You have active, serious autoimmune conditions - You have previously received sacituzumab govitecan or similar antibody-drug treatments - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan-hziy (SG)

Administered intravenously


Locations(16)

Los Angeles Cancer Network (LACN) - Good Sam

Los Angeles, California, United States

Winship Cancer Institute - Emory University

Atlanta, Georgia, United States

The University of Kansas Hospital

Westwood, Kansas, United States

Siteman Cancer Center

St Louis, Missouri, United States

West Cancer Centre

Germantown, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Texas Oncology - DFW

Dallas, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

St. Vincent's Hospital - Kinghorn Cancer Center

Darlinghurst, New South Wales, Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

John Flynn Private Hospital

Tugun, Queensland, Australia

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06926920


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