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RECRUITING
NCT07399821
PHASE1/PHASE2

An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma

Sponsor: Princess Maxima Center for Pediatric Oncology

View on ClinicalTrials.gov

Summary

This is a non-randomized, open label phase Ib/II dose-escalation and expansion study designed to define the recommended dose of anti-GD2-800CW in pediatric neuroblastoma patients. The aim of this imaging study is to determine a safe and effective dose of anti-GD2-800CW for intra-operative detection of neuroblastoma using NIR fluorescence.

Official title: A Phase Ib/II First-in-human Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2025-11-05

Completion Date

2027-05-01

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

anti-GD2-800CW

Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery. In phase Ib, using a 3+3 design, a dose escalation is performed to determine the RP2D.

Locations (1)

Prinses Maxima Centrum

Utrecht, Netherlands