drugset / Trial / NCT06013618
Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
Phase 2
Recruiting
120 enrolled
Sun Yat-sen University Cancer Center
Hainan General Hospital · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an prospective study to evaluate the safety and efficacy of naxitamab monotherapy or combined with chemotherapy or combined with chemotherapy and checkpoint inhibitor in the treatment of pediatric high-risk and refractory/relapsed neuroblastoma in Sun Yat-sen University Cancer Center.
Timeline
- Start
- 2023-06-19
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Naxitamab | Monoclonal antibody | 2.25 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Temozolomide | Small molecule | 100 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Background | sargramostim | Protein / enzyme biologic | 500 ug/m2 | Subcutaneous |