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Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
Sponsor: Nammi Therapeutics Inc
Summary
Study QXL138AM-001 is a Phase 1a/1b study to investigate the safety, pharmacokinetics, and preliminary activity of QXL138AM in subjects with locally advanced un-resectable and/or metastatic solid tumors and multiple myeloma. The study is an open-label, multicenter, first in human study to be conducted in two major parts which are further organized into two sub-parts. Part A Dose Escalation is a modified 3+3 with the first two cohorts consisting of one subject each based on the low clinical starting dose. Dose escalation in solid tumors (Part A1) will be followed by dose finding in multiple myeloma (Part A2). Part B consists of dose expansion in solid tumors (Part B1) and multiple myeloma (Part B2) using the recommended dose for expansion from Part A
Official title: A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and/or Metastatic Solid Tumors and Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-08-28
Completion Date
2028-05-30
Last Updated
2024-09-03
Healthy Volunteers
No
Conditions
Interventions
QXL138AM Injection every 2 weeks by IV Infusion
masked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a
Locations (8)
University of Southern California
Los Angeles, California, United States
Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport, California, United States
Sarah Cannon Research Institute - Denver DDU
Denver, Colorado, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States
New York Cancer & Blood Specialists
New York, New York, United States
University of Rochester - Wilmot Cancer Institute
Rochester, New York, United States
START San Antonio
San Antonio, Texas, United States