Phase
Condition
Breast Cancer
Treatment
Sacituzumab Govitecan-hziy (SG)
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
St. Vincent's Hospital - Kinghorn Cancer Center
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
St. Vincent's Hospital - Kinghorn Cancer Center
Darlinghurst 2169378, New South Wales 2155400 2010
AustraliaActive - Recruiting
Sunshine Coast University Private Hospital
Birtinya 8348723, Queensland 2152274 4575
AustraliaActive - Recruiting
John Flynn Private Hospital
Tugun 2145929, Queensland 2152274 4224
AustraliaActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul 1835848, 03722
South KoreaSite Not Available
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California 90017
United StatesSite Not Available
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles 5368361, California 5332921 90017
United StatesActive - Recruiting
Winship Cancer Institute - Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Winship Cancer Institute - Emory University
Atlanta 4180439, Georgia 4197000 30322
United StatesActive - Recruiting
The University of Kansas Hospital
Westwood 4281639, Kansas 4273857 66205
United StatesActive - Recruiting
Siteman Cancer Center
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
West Cancer Centre
Germantown, Tennessee 38138
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
West Cancer Centre
Germantown 4624601, Tennessee 4662168 38138
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Tennessee Oncology, PLLC
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Texas Oncology - DFW
Dallas 4684888, Texas 4736286 75246
United StatesActive - Recruiting
Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.