The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in patients with advanced solid tumors. The escalation part of the study will determine the maximum tolerated dose (MTD).
VX15/2503-01 is a dose-escalation, open label study to evaluate the safety and tolerability of IV administered VX15/2503 in patients with advanced solid tumors. This will be accomplished by using a dose escalation procedure starting at low doses of VX15/2503 and will continue based on predefined parameters until the maximum tolerated dose is identified. The study drug, VX15/2503, is a monoclonal antibody that binds to the semaphorin 4D (SEMA4D; CD100) antigen. Semaphorins have been shown to play an important role in certain physiological processes such as vascular growth, tumor progression and immune cell regulation. Experimental evidence suggests that SEMA4D has two mechanisms of action that result in angiogenesis and tumor proliferation and invasion. Antibody neutralization of SEMA4D thus may represent a new therapeutic strategy for cancer treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Dose escalation will begin at low doses and will gradually increase in each future cohort. The current trial design provides for 7 study cohorts with a 20 mg/kg expansion phase.
Virginia G. Piper Cancer Center at Scottsdale Healthcare
Scottsdale, Arizona, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Safety/tolerability as measured by number of patients with adverse events
Subject incidence of treatment-emergent adverse events
Time frame: Up to 18 months
Maximum tolerated dose as measured by frequency of dose limiting toxicities
Time frame: Four (4) weeks after first dose
Peak plasma concentration (Cmax) of VX15/2503
Time frame: Four (4) hours after start of infusion
Area under the plasma concentration versus time curve (AUC) of VX15/2503
Time frame: Up to seven (7) days after first dose
Half-life of VX15/2503
Time frame: Up to 14 days after first dose
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