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Evaluation of Safety, Tolerability, PK & PD of Intravenous VX15/2503 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT01313065
Recruitment Status : Completed
First Posted : March 11, 2011
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Vaccinex Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: VX15/2503 Phase 1

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: VX15/2503
VX15/2503 monoclonal antibody at a concentration of 0.3 mg/kg - 20 mg/kg to be administered intravenously on a weekly dosing cycle.
 Drug: VX15/2503
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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety/tolerability as measured by number of patients with adverse events [ Time Frame: Up to 18 months ]
    Subject incidence of treatment-emergent adverse events

  2. Maximum tolerated dose as measured by frequency of dose limiting toxicities [ Time Frame: Four (4) weeks after first dose ]

Secondary Outcome Measures :
  1. Peak plasma concentration (Cmax) of VX15/2503 [ Time Frame: Four (4) hours after start of infusion ]
  2. Area under the plasma concentration versus time curve (AUC) of VX15/2503 [ Time Frame: Up to seven (7) days after first dose ]
  3. Half-life of VX15/2503 [ Time Frame: Up to 14 days after first dose ]

Other Outcome Measures:
  1. SEMA4D T cell percent saturation of VX15/2503 [ Time Frame: Up to 18 months ]
  2. Number of patients who develop anti-drug antibody [ Time Frame: Up to 18 months ]
  3. Overall response rate (ORR) using RECIST 1.1 [ Time Frame: Up to 18 months ]
  4. Progression-free survival (PFS) using RECIST 1.1 [ Time Frame: Up to 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Patients 18 yrs or older with confirmed histological or cytological advanced solid tumors, relapsed or refractory to standard treatment for which no curative therapy is available; patients must demonstrate progressive disease prior to entry
  • Has measurable disease as defined by RECIST1.1
  • Life expectancy of at least 3 months (per investigator assessment)
  • ECOG performance status of 0-2
  • Adequate bone marrow, renal and liver function
  • Recovered from any significant prior toxicity of previous anti-neoplastic therapy
  • For patients of reproductive potential, is willing to use a medically acceptable form of contraception throughout the study period and for at least 4 weeks after the last dose of VX15/2503
  • Expansion cohort - patients in this cohort must have one of the following characteristics:
  • A diagnosis of a pancreatic neuroendocrine tumor OR
  • A diagnosis of a soft tissue sarcoma OR
  • A diagnosis of a bone metastasis OR
  • A diagnosis of advanced solid tumor AND a T cell count of at least 1500 cells/uL OR a B cell count of at least 250 cells/uL at screening

Main Exclusion Criteria:

  • Treatment with anti-neoplastic agents (chemotherapy, immunotherapy, radiotherapy or endocrine therapy) within 3 weeks prior to start of study treatment
  • Treatment with an investigational agent within 4 weeks prior to start of study treatment
  • Is on concurrent anti-neoplastic therapy with the exception of continuing luteinizing hormone-releasing hormone agonist/antagonist therapy for patients with castrate-resistant prostate cancer
  • Treatment with oral or parenteral corticosteroids in excess of 10mg/day of prednisolone or equivalent for more than 5 days within 4 weeks prior to start of study treatment or a requirement for systemic immunosuppressive therapy for any reason
  • Untreated brain Mets or CNS tumor involvement
  • Any other intercurrent illness or condition which could impact patient compliance or ability to complete the study
  • Sensitivity to VX15/2503 or the ingredients or excipients of VX15/2503
  • Pregnant or breast-feeding women (women of child-bearing potential must have negative serum pregnancy test within 3 days prior to receiving the first dose of VX15/2503)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Vaccinex Inc.
PPD
Investigators
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Principal Investigator: Amita Patnaik, MD South Texas Accelerated Research Therapeutics, LLC
Principal Investigator: Ramesh K Ramanathan, MD TGen Clinical Research Service at Scottsdale Healthcare
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vaccinex Inc.
ClinicalTrials.gov Identifier: NCT01313065    
Other Study ID Numbers: VX15/2503-01 v.9
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Vaccinex Inc.:
VX15/2503
Semaphorin 4D
SEMA4D
CD100
safety
 tolerability
pharmacokinetics
pharmacodynamics
advanced solid tumors
Additional relevant MeSH terms:
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Neoplasms