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

NCT01313065 | Completed Phase 1

• 1 other identifier: VX15/2503-01 v.9
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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).

Conditions

Solid Tumors

Keywords

VX15/2503; Semaphorin 4D; SEMA4D; CD100; safety; tolerability; pharmacokinetics; pharmacodynamics; advanced solid tumors

Outcome Measures

Primary Outcomes (2)

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

  Subject incidence of treatment-emergent adverse events

  Up to 18 months

• Maximum tolerated dose as measured by frequency of dose limiting toxicities

  Four (4) weeks after first dose

Secondary Outcomes (3)

• Peak plasma concentration (Cmax) of VX15/2503

  Four (4) hours after start of infusion

• Area under the plasma concentration versus time curve (AUC) of VX15/2503

  Up to seven (7) days after first dose

• Half-life of VX15/2503

  Up to 14 days after first dose

Other Outcomes (4)

• SEMA4D T cell percent saturation of VX15/2503

  Up to 18 months

• Number of patients who develop anti-drug antibody

  Up to 18 months

• Overall response rate (ORR) using RECIST 1.1

  Up to 18 months

Study Arms (1)

VX15/2503

EXPERIMENTAL

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

Interventions

VX15/2503 DRUG

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.

VX15/2503

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vaccinex Inc.: lead
• PPD Development, LP: collaborator

Study Sites (2)

Virginia G. Piper Cancer Center at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Worzfeld T, Offermanns S. Semaphorins and plexins as therapeutic targets. Nat Rev Drug Discov. 2014 Aug;13(8):603-21. doi: 10.1038/nrd4337.

  PMID: 25082288 DERIVED

Study Officials

• Amita Patnaik, MD

  South Texas Accelerated Research Therapeutics, LLC

  PRINCIPAL INVESTIGATOR

• Ramesh K Ramanathan, MD

  TGen Clinical Research Service at Scottsdale Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 11, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

US (2)