195
Participants
Start Date
January 9, 2023
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2029
BXQ-350
BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 will be administered by intravenous (IV) infusion over six months and continued for an additional 20 months for participants who remain eligible.
Placebo
Placebo will be 0.9% normal saline of matching volume to BXQ-350 administered by intravenous (IV) infusion over six months and continued for an additional 20 months for participants who remain eligible (Stage 2 only)
Stony Brook Cancer Center, Stony Brook
Sylvester Comprehensive Cancer Center, University of Miami Hospitals and Clinics, Miami
University of Alabama at Birmingham, Birmingham
University of Louisville, James Graham Brown Cancer Center, Louisville
University of Kentucky/Markey Cancer Center, Lexington
St. Elizabeth Healthcare, Edgewood
Gabrail Cancer Center Research, Canton
University of Cincinnati Medical Center, Cincinnati
The University of Iowa Hospitals and Clinics, Iowa City
University Medical Center New Orleans, New Orleans
UC Irvine Health, Orange
Pacific Hematology Oncology Associates, San Francisco
Lead Sponsor
Collaborators (2)
ICON plc
INDUSTRY
CTI Clinical Trial and Consulting Services
OTHER
Bexion Pharmaceuticals, Inc.
INDUSTRY