ANTI-GD2-800CW for Neuroblastoma

Inclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients older than 1 year of age and not older than 18 years."}
• {"criterion_text":"- Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations"}

Exclusion criteria

• {"criterion_text":"- Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Breast feeding."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients that received prior treatment with chimeric antibodies."}

Primary endpoints

• {"endpoint_text":"- Anti-GD2-800CW related adverse events not to be expected from Dinutuximab-alone infusion","definition_or_measurement_approach":""}
• {"endpoint_text":"- Tumor to background ratio (TBR) of at least 2.0 ex vivo and sufficient for detection during surgery. TBR is established by dividing the mean fluorescence signal of the tumor by the mean fluorescence signal of the background. Background is determined by fluorescence intensity in healthy kidney, liver and surrounding background tissue.","definition_or_measurement_approach":"TBR defined as mean fluorescence signal of tumor divided by mean fluorescence signal of background; background determined by fluorescence intensity in healthy kidney, liver and surrounding background tissue; target TBR ≥ 2.0 ex vivo and sufficient for detection during surgery."}

Secondary endpoints

• {"endpoint_text":"- Pharmacokinetics of anti-GD2-800CW; blood samples will be taken at t=0 (just before infusion), t=8h (directly after infusion), t=24h (after infusion), t=72h (after infusion), t=96h (immediately before surgery), t=120h (24h after surgery), t=144h (48h after surgery) and t=192h (4 days after surgery).","definition_or_measurement_approach":"PK measured from blood samples taken at specified timepoints relative to infusion and surgery (t=0, 8h, 24h, 72h, 96h, 120h, 144h, 192h)."}
• {"endpoint_text":"- The sensitivity and specificity of anti-GD2-800CW to detect GD2-expressing, vital tumor cells. Pathologic status of removed fluorescent tissue and of removed fluorescent tissue will be compared to fluorescent status.","definition_or_measurement_approach":"Compare pathologic status of removed fluorescent tissue to fluorescent status to calculate sensitivity and specificity for detection of GD2-expressing vital tumor cells."}
• {"endpoint_text":"- Clinical visibility: 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.","definition_or_measurement_approach":"Intra-operative visibility rated by three surgeons on a 1-5 Likert scale; primary threshold is score ≥4.0 indicating clear distinction between tumor and surrounding tissue based on fluorescence."}

Netherlands

Earliest CTIS Part Ii Submission Date

07-04-2025

Latest Decision Or Authorization Date

22-04-2025

Processing Time Days

15

Number Of Sites

1

Number Of Participants

22

Primary sponsor

Full Name

Prinses Maxima Centrum voor Kinderoncologie B.V.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands