Tests naxitamab, with or without chemotherapy, in children with neuroblastoma
Tests naxitamab alone or with other drugs in children with high-risk or relapsed neuroblastoma.
Plain-language title generated from the registry record
Registry title: Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-Sen University Cancer Center
- Trial code
- NCT06013618
- Record updated
- 17 June 2025
- Original description
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.Read full original descriptionShow less
Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
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.
Inclusion: 1)Confirmed diagnosis of high-risk NB 2)1 year of age or above 3)Patient or parent/guardian must provide written informed consent to participate 4)If patient is sexually active, the patient agrees to use effective contraception 5)Confirmed negative urine pregnancy test for sexually active female of child-bearing potential (post-menarche).
Exclusion: Patient is pregnant, planning to become pregnant (while being treated with naxitamab) or is currently breastfeeding; Patient will undergo treatment with another investigational drug, whilst being treated with naxitamab or has received another investigational drug within the 4 weeks prior to commencing treatment with naxitamab; Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry < 94% and/or abnormal pulmonary function tests if these assessments are clinically indicated; Applicable for treatment with naxitamab in combination with GM-CSF only:; Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components; Patient is unable to comply with the naxitamab treatment or has a medical condition that would potentially increase the severity of the toxicities experienced from naxitamab treatment at the discretion of the treating physician; Patient has active progression of the NB disease; Patient has active NB disease at primary site or soft-tissue metastasis; Left ventricular ejection fraction of <50% by echocardiography OR other clinically relevant cardiac disorders at the discretion of the investigator; Significant organ toxicity; Patient is either eligible and able to participate in or is currently participating in an active interventional Y-mAbs sponsored clinical trial with naxitamab within the indication applied for; Patient has known CNS metastases when initiating naxitamab treatment.