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

NCT06013618 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hainan General Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yizhuo Zhang · SunYat Sen University Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-19
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06013618 on ClinicalTrials.gov