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

NCT07399821 | Recruiting Phase 1 DMC

• 1 other identifier: 2023-507596-22-00
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Neuroblastoma

Keywords

Neuroblastoma; Fluorescence Guided Surgery; NIR fluorescence; pediatric oncology

Outcome Measures

Primary Outcomes (2)

• To establish the recommended phase 2 dose (RP2D), based on efficacy and safety, of the anti-GD2-800CW fluorescent imaging agent in pediatric patients with neuroblastoma.

  Establishing the recommended phase 2 dose (RP2D), based on efficacy and safety, of the anti-GD2-800CW fluorescent imaging agent.

  Through escalation phase completion, an average of 1 year.

• To investigate safety of anti-GD2-800CW based on treatment related new AEs.

  Registration of new AEs.

  From IMP administration to 4 days after surgery

Secondary Outcomes (5)

• To assess the pharmacodynamic characteristics of an i.v. injection of anti-GD2-800CW.

  From just before infusion to 4 days after surgery.

• To assess the pharmacokinetic characteristics of an i.v. injection of anti-GD2-800CW.

  From just before infusion to 4 days after surgery.

• To correlate clinical imaging data with histopathology data to determine the accuracy for depicting GD-2 expressing vital tumor cells.

  From start surgery to 3 weeks after surgery when the PA results are analyzed.

• To assess the intra-operative usability of anti-GD2-800CW to distinguish tumor tissue from surrounding tissue on eyesight of the surgeons.

  From start surgery to 3 weeks after surgery when the PA results are analyzed.

• To assess whether tumor load influences the fluorescence intensity.

  From pre-operative scan to when PA results are analyzed, 3 weeks after surgery.

Study Arms (1)

anti-GD2-800CW

EXPERIMENTAL

Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery.

Drug: anti-GD2-800CW

Interventions

anti-GD2-800CW DRUG

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.

anti-GD2-800CW

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with the diagnosis of neuroblastoma as defined by histopathology (confirmed by the PMC Department of Pathology), who will be operated for NB as standard of care procedure
• Patients older than 1 year of age and not older than 18 years.
• Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations

You may not qualify if:

• Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy
• Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within during the screening period and before the administration of the IMP.
• Breast feeding.
• Sexually active participants not willing to use highly effective contraceptive method (pearl index \<1) as defined in CTFG HMA 2020 (Appendix I) during trial participation and until 6 months after end of protocol therapy.
• Patients that received prior treatment with chimeric antibodies.

Sponsors & Collaborators

• Princess Maxima Center for Pediatric Oncology: lead

Study Sites (1)

Prinses Maxima Centrum

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Marieke Kietselaer

CONTACT

+31 88 972 7272; trialmanagement@prinsesmaximacentrum.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will receive a single infusion of anti-GD2-800CW. There will be 3 different dose levels investigated in the GLOW-FISH trial.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: February 10, 2026
• Study Start: November 5, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)