An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-18
SponsorPrincess Maxima Center for Pediatric Oncology
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
anti-GD2-800CW
DrugParticipants 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.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: anti-GD2-800CWExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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 surgerySecondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov