A Phase 1/2 interventional study of anti-GD2-800CW in Neuroblastoma, sponsored by Princess Maxima Center for Pediatric Oncology. Recruiting at 1 site in Netherlands. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Princess Maxima Center for Pediatric Oncology · Phase 1/2, Interventional, and Treatment
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.
Neuroblastoma is the most commonly diagnosed extracranial solid tumor in young children. It is a neural crest derived malignancy, which are the cells that give rise to the sympathetic nervous system, and can therefore be located in different body compartments. However, it occurs most frequently (80%) in the abdomen. Current treatment involves debulking surgery using standard-of-care, not assisted by intra-operative visualization of the tumor. In this current situation there is, i) a high risk of severe complications such as bleeding or unplanned nephrectomy (40%), ii) a high chance of >10% residual tumor tissue, and iii) difficulty distinguishing neuroblastoma subtypes with varying malignancy. Therefore, there is a high need for new tools enabling tumor-specific intra-operative visualization to assist the surgeon. This will reduce surgical complications and ensure neuroblastoma cells can be visualized and resected during surgery. Over the past years, Fluorescence Guided Surgery (FGS) has proven to be a useful intraoperative tool to increase the visibility of the tumor in various adult cancers. Our group has developed and validated a tumor-specific fluorescent agent, anti-GD2-800CW, that can be used to visualize neuroblastoma during surgery. Anti-GD2-800CW consists of two substances. Firstly, the monoclonal antibody anti-GD2, also known as Qarziba or Dinutuximab-beta, which binds to Disialoganglioside 2 (GD2), a tumor-associated antigen specifically expressed by neuroblastoma, most melanomas and several other tumors. Immunotherapy with anti-GD2 is now standard therapy for high-risk neuroblastoma treatment in patients aged 12 months and above. Secondly, the near-infrared (NIR) fluorescent dye, IRDye800CW, which is used extensively in clinical trials as fluorescent imaging agent without any known adverse events (AEs). The aim of this study is to investigate the safety and efficacy of this novel agent, anti-GD2-800CW, to visualize neuroblastoma during surgery.
625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.
This study's planned enrollment of 22 is below the median of 32 across 475 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →Princess Maxima Center for Pediatric Oncology is the lead sponsor of 15 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery.
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.
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.
Time frame: 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.
Time frame: From IMP administration to 4 days after surgery
To assess the pharmacodynamic characteristics of an i.v. injection of anti-GD2-800CW.
Assessment will be done by measuring Anti Drug Antibody formation using an ADA binding assay. Blood samples will be taken at 8 time points.
Time frame: From just before infusion to 4 days after surgery.
To assess the pharmacokinetic characteristics of an i.v. injection of anti-GD2-800CW.
Assessment will be done by by measuring plasma levels Dinutuximab. Dinutuximab levels will be measured over time to create a concentration-time profile per patient. Blood samples will be taken at 8 time points.
Time frame: 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.
Pathologic status of removed fluorescent tissue and of removed fluorescent tissue will be compared to fluorescent status.
Time frame: 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.
Score of ≥ 4.0 on a Likert scale of 1-5 based on the judgement of three surgeons. They will grade the intra-operative visibility of the fluorescence and whether a clear distinction can be made on eyesight between tumor and surrounding tissue based on fluorescence.
Time frame: From start surgery to 3 weeks after surgery when the PA results are analyzed.
To assess whether tumor load influences the fluorescence intensity.
Tumor load will be examined in preoperative imaging with the tumor volume (cm3). Additionally, we will denote the histopathological outcome with an estimation of vital tumor present after resection.
Time frame: From pre-operative scan to when PA results are analyzed, 3 weeks after surgery.
Plan to share: No — Only IPD used in the results publication.
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Princess Maxima Center for Pediatric Oncology