Evaluating Naxitamab for Treating High-Risk Pediatric Neuroblastoma
Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
This study is testing a new treatment called naxitamab, alone or with other medicines, to see if it can help children with high-risk neuroblastoma feel better and improve their chances of recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Months and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | naxitamab, chemotherapy, axitamab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06013618 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 year or older with a confirmed diagnosis of high-risk neuroblastoma.
Not a fit: Patients with significant organ toxicity or known allergies to the treatment components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for children with high-risk neuroblastoma.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination therapy is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yizhuo Zhang, MD
- Email: zhangyzh@sysucc.org.cn
- Phone: 0087342460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.