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
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California 90017
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.