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

Launched by GILEAD SCIENCES · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to give a drug called sacituzumab govitecan to patients with advanced triple-negative breast cancer, a type that can be particularly hard to treat. The researchers want to find out if giving the drug at different doses and on a different schedule is safe and how well it works. They will look at how many patients respond to the treatment and how long they can live without the cancer getting worse.

To participate in this study, you need to be at least 18 years old and have been diagnosed with triple-negative breast cancer that has either come back after treatment or has not responded to standard therapies. It's important that your cancer cannot be surgically removed and that you have measurable disease confirmed by imaging tests. The trial is not yet recruiting participants, but if you meet these criteria, you may have the opportunity to join once it starts. Participants can expect close monitoring for safety and support throughout the study.

Gender

ALL

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.