Clinical trial · Interventional
An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
A Phase Ib/II First-in-human Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
NCT07399821CI-TRIAL-00102897GLOW-FISHrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-GD2-800CW | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-GD2-800CW
- description
- Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery.
- interventionNames
- Drug: anti-GD2-800CW
Primary outcomes (2)
- measure
- 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.
- timeFrame
- Through escalation phase completion, an average of 1 year.
- description
- Establishing the recommended phase 2 dose (RP2D), based on efficacy and safety, of the anti-GD2-800CW fluorescent imaging agent.
- measure
- To investigate safety of anti-GD2-800CW based on treatment related new AEs.
- timeFrame
- From IMP administration to 4 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.