Evaluating Naxitamab for Treating High-Risk Pediatric Neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and effectiveness of naxitamab, either alone or in combination with chemotherapy and checkpoint inhibitors, for children with high-risk or refractory/relapsed neuroblastoma. Participants will include those who have achieved complete response after initial treatments or those with residual disease. The study will be conducted at Sun Yat-sen University Cancer Center, where patients will receive naxitamab along with GM-CSF and potentially other chemotherapy agents. The goal is to improve treatment outcomes for this challenging pediatric cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

1. Significant organ toxicity
2. Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components.
3. Patient is pregnant, planning to become pregnant (while being treated with naxitamab) or is currently breastfeeding
4. 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
5. 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
6. 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
7. Left ventricular ejection fraction of \<50% by echocardiography OR other clinically relevant cardiac disorders at the discretion of the investigator
8. 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:
9. Patient has active progression of the NB disease
10. Patient has active NB disease at primary site or soft-tissue metastasis
11. Patient has known CNS metastases when initiating naxitamab treatment

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yizhuo Zhang, MD
• Email: zhangyzh@sysucc.org.cn
• Phone: 0087342460

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prolonged Naxitamab with irinotecan, temozolomide, and sargramostim for relapsed or refractory neuroblastoma

  This trial will test whether giving the immunotherapy Naxitamab more slowly, along with irinotecan, temozolomide, and sargramostim, reduces infusion side effects for people with relapsed or refractory neuroblastoma.

  Recruiting at 2 sites Phase 1 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT07027748

• Combining tipifarnib and naxitimab for treating relapsed neuroblastoma

  This study is testing a new combination of an oral drug called tipifarnib and an intravenous drug called naxitimab to see if it can help children with relapsed neuroblastoma.

  Recruiting at 12 sites Phase 2 Milton S. Hershey Medical Center · Little Rock, Arkansas and 11 other locations · NCT06540963

• Naxitamab added to standard chemotherapy for high-risk neuroblastoma

  This study is testing if adding a new treatment called naxitamab to regular chemotherapy can help children with high-risk neuroblastoma do better and live longer.

  Recruiting at 25 sites Phase 2 Milton S. Hershey Medical Center · Birmingham, Alabama and 25 other locations · NCT05489887

• Neuroblastoma patients' genomic and biological profile study

  This multicenter, prospective study tests profiles from blood, tumor tissue, and bone marrow to understand neuroblastoma in diagnosed, relapsed, or refractory patients.

  Recruiting at 35 sites Istituto Giannina Gaslini · Ancona and 34 other locations · NCT07881172

• CIML-NK Cells to Treat Neuroblastoma in Relapsed or Refractory Patients

  We’re testing whether donor-derived cytokine-induced memory-like NK cells can be safely given with dinutuximab to kids and young adults whose neuroblastoma has come back or not responded to treatment.

  Recruiting Phase 2 Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07635056

• Becotatug Vedotin for EGFR-positive relapsed, refractory, or metastatic pediatric solid tumors

  This trial will test Becotatug Vedotin, an EGFR-targeted antibody-drug conjugate, to see if it is safe and helps children aged 2–18 with EGFR-positive relapsed, refractory, or metastatic solid tumors.

  Recruiting Phase 1 Sun Yat-sen University · Guangzhou, Guangdong · NCT07584499

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.