Evaluation of Safety, Tolerability, PK & PD of Intravenous VX15/2503 in Patients With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01313065|
Recruitment Status : Completed
First Posted : March 11, 2011
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: VX15/2503||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of VX15/2503 in Adult Patients With Advanced Solid Tumors|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
VX15/2503 monoclonal antibody at a concentration of 0.3 mg/kg - 20 mg/kg to be administered intravenously on a weekly dosing cycle.
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.
- Safety/tolerability as measured by number of patients with adverse events [ Time Frame: Up to 18 months ]Subject incidence of treatment-emergent adverse events
- 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 ]
- SEMA4D T cell percent saturation of VX15/2503 [ Time Frame: Up to 18 months ]
- Number of patients who develop anti-drug antibody [ Time Frame: Up to 18 months ]
- Overall response rate (ORR) using RECIST 1.1 [ Time Frame: Up to 18 months ]
- Progression-free survival (PFS) using RECIST 1.1 [ Time Frame: Up to 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313065
|United States, Arizona|
|Virginia G. Piper Cancer Center at Scottsdale Healthcare|
|Scottsdale, Arizona, United States, 85258|
|United States, Texas|
|South Texas Accelerated Research Therapeutics, LLC|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Amita Patnaik, MD||South Texas Accelerated Research Therapeutics, LLC|
|Principal Investigator:||Ramesh K Ramanathan, MD||TGen Clinical Research Service at Scottsdale Healthcare|