NCT06926920

A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With 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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Phase 1 of this study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and efficacy of SG. Phase 2 expansion of this study will further evaluate the safety, efficacy, and PK of SG.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan-hziy (SG)	Administered intravenously

Timeline

• Start date: 2025-04-30
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-04-15
• Last updated: 2026-01-30

Locations

16 sites across 3 countries: United States, Australia, South Korea

Regulatory

• FDA-regulated drug study