NCT06013618

Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sun Yat-Sen University Cancer Center · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with high risk neuroblastoma who obtain CR after chemotherapy combined with surgery, radiotherapy and/or hematopoietic stem cell transplantation received axitamab and GM-CSF. Patients with high-risk neuroblastoma treated by chemotherapy combined with surgery, radiotherapy and or hematopoietic stem cell transplantation patients with tumor residual or progression during treatment (refractory) received naxitamab and GM-CSF in combination with irinotecan and temozolomide or naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Naxitamab monotherapy	Naxitamab is administered on days 1, 3, and 5
DRUG	GM-CSF	Each treatment cycle is 28 days and is started with five days (days -4 to 0) of GM-CSF administered at 250 mcg/m2/day in advance of the start of naxitamab infusion. GM-CSF is thereafter administered at 500 mcg/m2/day on days 1 to 5.
DRUG	Irinotecan	Each HITS treatment cycle is 21 days. Irinotecan intravenously (IV) at 50 mg/m2/day will be administered from Day 1-5 concurrently with temozolomide orally at 150 mg/m2/day or 100 mg/m2/day.
DRUG	Temozolomide	Each HITS treatment cycle is 21 days. Irinotecan intravenously (IV) at 50 mg/m2/day will be administered from Day 1-5 concurrently with temozolomide orally at 150 mg/m2/day or 100 mg/m2/day.
DRUG	Naxitamab in combination therapy	Naxitamab 2.25mg/kg IV will be administered on Days 2, 4, 8 and 10.
DRUG	GM-CSF with combination regimen	GM-CSF 250 mcg/m2/day will be administered subcutaneously on Days 6-10.
DRUG	Sintilimab	Sintilimab was administerd with 3mg/kg (max 200mg) on day 11 every 3 weeks.

Timeline

• Start date: 2023-06-19
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-08-28
• Last updated: 2025-06-17

Locations

1 site across 1 country: China