NCT02765165

Phase 1/2 Study of USL311 +/- Lomustine in Advanced Solid Tumors or Relapsed/Recurrent Glioblastoma Multiforme (GBM)

A Phase 1/2 Dose-escalation of USL311 as Single Agent and in Combination With Lomustine (CCNU) in Subjects With Advanced Solid Tumors, With Subsequent Single Agent and Combination Phase 2 Cohorts for Subjects With Relapsed/Recurrent Glioblastoma Multiforme (GBM)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Proximagen, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase 1/2, dose-escalation and dose expansion study of a CXCR4 inhibitor, USL311, alone and in combination with lomustine in subjects with advanced solid tumors (Phase 1) and subjects with relapsed/recurrent GBM (Phase 2). The study is designed to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of USL311 alone and in combination with lomustine.

Conditions

• Solid Tumors (Phase 1)
• Relapsed/Recurrent GBM (Phase 2)

Interventions

Type	Name	Description
DRUG	USL311	Administered once weekly in a 21-day cycle
DRUG	USL311	Administered once daily in a 21-day cycle
DRUG	USL311	Administered once daily in a 42-day cycle
DRUG	Lomustine	Administered once every 6 weeks in a 42-day cycle

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2016-05-06
• Last updated: 2021-07-23
• Results posted: 2021-07-23

Locations

6 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study