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Official Title

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

Phase
Phase 1/Phase 2
Sponsor
Gilead Sciences
Enrollment
100
Timeline
Apr 2025 → Jun 2028
About This Study

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 Criteria

Inclusion Criteria

  • 1Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
  • 2Histologically or cytologically locally confirmed TNBC.
  • 3Phase 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.
  • 4Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.
  • 5Phase 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.
  • 6Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.
  • 7During Phase 1 safety run-in, individuals must be UGT1A1 wild-type.
  • 8After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.
  • 9Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.
  • 10Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • 11Adequate hematologic counts within 2 weeks prior to enrollment.
  • 12Adequate hepatic and renal function.

Exclusion Criteria

  • 1Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
  • 2Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.

Locations

15 sites participating in this study

Winship Cancer Institute - Emory University

Atlanta, Georgia 30322

Recruiting

Los Angeles Cancer Network (LACN) - Good Sam

Los Angeles, California 90017

Recruiting

Siteman Cancer Center

St Louis, Missouri 63110

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →