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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vaccinex Inc.
• Collaborator: PPD

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)