NCT04319198

Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy

Open-label Rollover Study to Evaluate Long-Term Safety in Subjects With Metastatic Solid Tumors That Are Benefiting From Continuation of Therapy With Sacituzumab Govitecan

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• 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), and how safe it is in participants with metastatic cancer (cancer that has spread).

Detailed description

This is a rollover study. Only participants who continue to receive clinical benefit from continuation of SG therapy and are tolerating therapy at the time of enrollment are eligible for this study. Participants enrolled may continue to receive SG at the dose that they were receiving in the Gilead parent study at the time of consenting to participate in this rollover study.

Conditions

• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan-hiy	Administered intravenously

Timeline

• Start date: 2020-08-04
• Primary completion: 2024-10-18
• Completion: 2024-10-18
• First posted: 2020-03-24
• Last updated: 2025-09-30
• Results posted: 2025-09-30

Locations

21 sites across 3 countries: United States, Belgium, France

Regulatory

• FDA-regulated drug study