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

NCT07399821 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-02-10

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Princess Maxima Center for Pediatric Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2027-04-01
Completion
2027-05-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399821 on ClinicalTrials.gov