A Phase Ib/II First-in-human Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
Prinses Maxima Centrum
RECRUITING
Utrecht
Contact Information
Primary
Marieke Kietselaer
trialmanagement@prinsesmaximacentrum.nl
+31 88 972 7272
Time Frame
Start Date: 2025-11-05
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 22
Treatments
Experimental: anti-GD2-800CW
Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery.
Related Therapeutic Areas
Sponsors
Leads: Princess Maxima Center for Pediatric Oncology