A Phase 1/2 Trial of VX15/2503 in Children Adolescents or Young Adults With Recurrent or Relapsed Solid Tumors

Study Overview

This phase I/II trial studies the side effects and best dose of anti-SEMA4D monoclonal antibody VX15/2503 (VX15/2503) and to see how well it works in treating younger patients with solid tumors that have come back after treatment, or do not respond to treatment.

Study Description

The purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of VX15/2503 administered as an intravenous infusion every 14 days to children with recurrent or refractory solid tumors; to define and describe the toxicities of VX15/2503 administered on this schedule; to characterize the pharmacokinetics of VX15/2503 in children with recurrent or refractory cancer; to preliminarily define the antitumor activity of VX15/2503 for the treatment of relapsed or refractory osteosarcoma; and to determine if VX15/2503 either improves the disease control rate at 4 months in patients with recurrent measurable osteosarcoma or produces an objective response rate in patients with relapsed or refractory osteosarcoma.

Additional Information

Participants will not be paid for their participation.


  • IRB Number: 1802267915 (PHO-CROOP-COG-ADVL1614)
  • Research Study Identifier: TX8633
  • Principal Investigator: James Croop, MD, PhD

Recruitment Status

Open

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