Testing a new dosing schedule of sacituzumab govitecan for 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

This study is testing a new way to give a cancer drug called sacituzumab govitecan to see if it is safe and effective for people with advanced triple-negative breast cancer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gilead Sciences (industry)
• Drugs / interventions: chemotherapy, sacituzumab
• Locations: 16 sites (Los Angeles, California and 15 other locations)
• Trial ID: NCT06926920 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) administered at an alternative dose and schedule in patients with advanced triple-negative breast cancer (TNBC). The study consists of two phases: Phase 1 focuses on assessing the preliminary safety, tolerability, pharmacokinetics, and efficacy of SG, while Phase 2 will further investigate these aspects in a larger cohort. The primary objectives include measuring the objective response rate and progression-free survival among participants.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with unresectable, locally advanced or metastatic TNBC who meet specific treatment history criteria.

Not a fit: Patients with early-stage triple-negative breast cancer or those who have not received prior systemic therapy for advanced disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced triple-negative breast cancer who have limited therapeutic alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced triple-negative breast cancer, but this specific dosing schedule is novel.

Eligibility criteria

Key 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.

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.

Where this trial is running

Los Angeles, California and 15 other locations

• Los Angeles Cancer Network (LACN) - Good Sam — Los Angeles, California, United States (RECRUITING)
• Winship Cancer Institute - Emory University — Atlanta, Georgia, United States (RECRUITING)
• The University of Kansas Hospital — Westwood, Kansas, United States (RECRUITING)
• Siteman Cancer Center — St Louis, Missouri, United States (RECRUITING)
• West Cancer Centre — Germantown, Tennessee, United States (RECRUITING)
• SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States (RECRUITING)
• Texas Oncology - DFW — Dallas, Texas, United States (RECRUITING)
• Virginia Oncology Associates — Norfolk, Virginia, United States (RECRUITING)
• St. Vincent's Hospital - Kinghorn Cancer Center — Darlinghurst, New South Wales, Australia (RECRUITING)
• Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (RECRUITING)
• John Flynn Private Hospital — Tugun, Queensland, Australia (RECRUITING)
• Seoul National University Hospital — Seoul, South Korea (RECRUITING)
• Severance Hospital, Yonsei University Health System — Seoul, South Korea (NOT_YET_RECRUITING)
• Asan Medical Center — Seoul, South Korea (RECRUITING)
• Samsung Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Gilead Clinical Study Information Center

Conditions: Triple Negative Breast Cancer