NCT05305365

Study Assessing QBS72S For Treating Brain Metastases

Phase IIa Study Assessing QBS72S For Treating Brain Metastases

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of QBS72S in participants with advanced, relapsed, metastatic cancer with CNS involvement

Detailed description

Primary Objective 1\. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through overall response rate (ORR) in Cohort 1 (Stages 1+2). Secondary Objectives 1. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through progression free survival (PFS) in Cohort 1 (Stages 1+2). 2. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through overall survival (OS) in Cohort 1 (Stages 1+2). 3. Test of the preliminary efficacy of the intracranial anti tumor activity of QBS72S through durations of response (DoR) in Cohort 1 (Stages 1+2). 4. Evaluate safety of QBS72S treatment in Cohort 1 (Stages 1+2), Cohort 2, and Cohort 3.

Conditions

• Brain Metastases
• Breast Cancer
• Lung Cancer
• Leptomeningeal Disease
• LMD

Interventions

Type	Name	Description
DRUG	QBS72S	QBS72S 18mg/m2 injection given intravenous once a month.

Timeline

• Start date: 2022-08-16
• Primary completion: 2025-06-20
• Completion: 2027-12-01
• First posted: 2022-03-31
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study