OncoMatch/Clinical Trials/NCT06485947
Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma
Is NCT06485947 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Dinutuximab beta and chemotherapy treatment called GPOH for neuroblastoma.
Treatment: Dinutuximab beta · chemotherapy treatment called GPOH · chemotherapy treatment called rapid COJEC — The goal of this clinical trial is to to assess the dose level of dinutuximab Beta (DB) when combined with 2 different induction chemotherapy regimens (named GPOH or rapid COJEC) in newly diagnosed high-risk neuroblastoma patients. The main question is: • to assess the safety and tolerability and identifying the recommended phase II dose and/or the maximum tolerable dose of dinutiximab Beta when combined with 2 standard induction chemotherapy regimens Participants will receive: * GPOH + dinutuximab beta infusion duration = 10 mg/m2 × 5 days (50 mg/m2/course) in 21-day treatment intervals. * Rapid COJEC + dinutuximab beta infusion duration = 10 mg/m2 × 3 days (30 mg/m2/course) in 10-day treatment intervals.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: cancer-specific treatment for neuroblastoma
Previous cancer-specific treatment for neuroblastoma
Lab requirements
Kidney function
Calculated glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine <1.5 × ULN corrected for age
Liver function
Alanine transaminase and aspartate aminotransferase <10 × ULN, total bilirubin <1.5 × ULN based on age specific reference ranges
Cardiac function
Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) >50% as determined by echocardiography or MUGA
Alanine transaminase and aspartate aminotransferase <10 × upper limit of normal (ULN), total bilirubin <1.5 × ULN based on age specific reference ranges. Calculated glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine <1.5 × ULN corrected for age. Shortening fraction (SF) ≥27% and/or left ventricular ejection fraction (LVEF) >50% as determined by echocardiography or MUGA.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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