drugset / Trial / NCT02765165
Phase 1/2 Study of USL311 +/- Lomustine in Advanced Solid Tumors or Relapsed/Recurrent Glioblastoma Multiforme (GBM)
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-04
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lomustine | Small molecule | 90 mg/m2 | Oral |
| Subject | USL311 | Small molecule | 40 mg | Intravenous |
| Subject | USL311 | Small molecule | 60 mg/m2 | Intravenous |