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

NCT02765165 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-07-23

Study results available
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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

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

Sponsors & Collaborators

  • Proximagen, LLC

    lead INDUSTRY

Principal Investigators

  • Tze-Chiang Meng, MD · Proximagen, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-07-01
Completion
2020-07-01
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02765165 on ClinicalTrials.gov