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

Launched by SUN YAT-SEN UNIVERSITY · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called naxitamab for children with high-risk neuroblastoma, which is a type of cancer that primarily affects young children. The trial is looking at how safe and effective naxitamab is when given alone or in combination with chemotherapy, and sometimes with an additional treatment to help the immune system fight the cancer. The research is being conducted at the Sun Yat-sen University Cancer Center and is currently recruiting participants.

To be eligible for the trial, children must be at least one year old and have a confirmed diagnosis of high-risk neuroblastoma. Parents or guardians must provide written consent for their child to participate. However, certain factors may exclude a child from joining, such as having serious health issues, being pregnant or breastfeeding, or having received other investigational drugs recently. Participants will receive treatment and will be closely monitored for any side effects or changes in their condition. This trial aims to find better ways to help children with this challenging cancer.

Gender

ALL

Eligibility 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