RecruitingPhase 2NCT06013618

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


Sponsor

Sun Yat-Sen University Cancer Center

Enrollment

120 participants

Start Date

Jun 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This study is evaluating naxitamab (hu3F8), an antibody treatment, in children with high-risk or relapsed/refractory neuroblastoma (a type of cancer that primarily affects young children and forms in nerve tissue). Naxitamab targets a protein called GD2 found on neuroblastoma cells. **You may be eligible if...** - You (or your child) are at least 1 year old - You have a confirmed diagnosis of high-risk neuroblastoma, or neuroblastoma that has come back or isn't responding to treatment - You (or your child's guardian) can provide written consent - You are using effective contraception if sexually active **You may NOT be eligible if...** - You have significant toxicity to vital organs - You have a known allergy to anti-GD2 antibodies or GM-CSF - You are pregnant, planning to become pregnant, or breastfeeding - You are currently taking another experimental drug or within 4 weeks of having done so - You are already enrolled in an active Y-mAbs sponsored naxitamab trial - Your heart function is below 50% (ejection fraction) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNaxitamab monotherapy

Naxitamab is administered on days 1, 3, and 5

DRUGGM-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.

DRUGIrinotecan

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.

DRUGTemozolomide

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.

DRUGNaxitamab in combination therapy

Naxitamab 2.25mg/kg IV will be administered on Days 2, 4, 8 and 10.

DRUGGM-CSF with combination regimen

GM-CSF 250 mcg/m2/day will be administered subcutaneously on Days 6-10.

DRUGSintilimab

Sintilimab was administerd with 3mg/kg (max 200mg) on day 11 every 3 weeks.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06013618


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