NCT04559230

Sacituzumab Govitecan in Recurrent Glioblastoma

A Phase II, Multicenter, Prospective Study of Sacituzumab Govitecan in Recurrent Glioblastoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label single arm study. All patients will receive the study drug. The aim of the study is to compare overall survival (OS) of patients with recurrent brain tumor, known as Glioblastoma (GBM) having high levels of a protein, Trophoblast cell surface antigen 2 (Trop-2), expression on treatment with Sacituzumab Govitecan (SG) versus lomustine only which has been used in the past.

Detailed description

Subjects are expected to participate for up to treatment duration with continued follow up for survival until one year after the last dose of study drug. The total duration of the active part of the study for each subject will be approximately 18 weeks, divided as follows: * Up to 3 weeks predose (screening period) * 3-week treatment periods of Sacituzumab govitecan * Study termination visit 3-4 weeks after last dose of study medication When a subject has completed the study termination or early termination visit, he/she and/or a family member will be contacted for survival information every 3 months until one year from last study dose.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan	Sacituzumab Govitecan will be administered by IV infusion over 3 hours for first administration and over 1 hour if tolerated. Subjects will be allowed to continue treatment until they have evidence of significant treatment-related toxicity or progressive disease.

Timeline

• Start date: 2022-01-06
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2020-09-22
• Last updated: 2026-03-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study