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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

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


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.


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

- Has disease activity that can be monitored by imaging or tumor biomarker measurement

- 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety/tolerability as measured by number of patients with adverse events

Outcome Description:

Subject incidence of treatment-emergent adverse events

Outcome Time Frame:

Up to 18 months

Safety Issue:

Yes

Principal Investigator

Amita Patnaik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

South Texas Accelerated Research Therapeutics, LLC

Authority:

United States: Food and Drug Administration

Study ID:

VX15/2503-01 v.7

NCT ID:

NCT01313065

Start Date:

January 2011

Completion Date:

June 2014

Related Keywords:

  • Solid Tumors
  • VX15/2503
  • Semaphorin 4D
  • SEMA4D
  • CD100
  • safety
  • tolerability
  • pharmacokinetics
  • pharmacodynamics
  • advanced solid tumors
  • Neoplasms

Name

Location
South Texas Accelerated Research Therapeutics, Llc San Antonio, Texas  78229
Virginia G. Piper Cancer Center at Scottsdale Healthcare Scottsdale, Arizona  85258