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A Phase 1 / 2 Study of VX15 / 2503 in Children, Adolescents, or Young Adults with Recurrent or Relapsed Solid Tumors

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Trial Phase
Phase I
Phase II
Eligibility
12 Months - 30 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03320330
Protocol IDs
ADVL1614 (primary)
ADVL1614
NCI-2017-01103
Study Sponsor
COG Phase I Consortium

Summary

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. Monoclonal antibodies, such as VX15 / 2503, may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVES:
I. 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. (Part A)
II. To define and describe the toxicities of VX15/2503 administered on this schedule. (Parts A-B)
III. To characterize the pharmacokinetics of VX15/2503 in children with recurrent or refractory cancer. (Parts A-B)
IV. To preliminarily define the antitumor activity of VX15/2503 for the treatment of relapsed or refractory osteosarcoma. (Part B)
V. 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. (Part B)

SECONDARY OBJECTIVES:
I. To assess the pharmacodynamics of VX15/2503 through VX15/2503 saturation of T-lymphocytes.
II. To assess the immunogenicity of VX15/2503 in pediatric patients with recurrent or refractory cancer.

EXPLORATORY OBJECTIVES:
I. To evaluate potential biomarkers of VX15/2503 sensitivity including SEMA4D, PlexinB1, and other markers of immune cell infiltration in archival tumor tissues.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive VX15/2503 intravenously (IV) over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.
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