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New treatment option for Neuroblastoma
Official title Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
ClinicalTrials.gov ID: NCT06013618
What this study is testing
What is Naxitamab monotherapy?
Naxitamab monotherapy is an investigational medicine, being studied as a potential treatment for neuroblastoma.
Also referred to as hu3F8.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
You likely can't join if
- Significant organ toxicity
- Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components.
- 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...
- Patient is either eligible and able to participate in or is currently participating in an active treatment Y-mAbs sponsored clinical trial with...
- Patient is unable to comply with the naxitamab treatment or has a medical condition that would potentially increase the severity of the toxicities...
See the full eligibility 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...
- Significant organ toxicity
- Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components.
- 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
- Patient is either eligible and able to participate in or is currently participating in an active treatment Y-mAbs sponsored clinical trial with naxitamab within the indication applied for
- 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...
- Left ventricular ejection fraction of \<50% by echocardiography OR other clinically relevant cardiac disorders at the discretion of the investigator
- 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...
- Patient has active progression of the NB disease
- Patient has active NB disease at primary site or soft-tissue metastasis
- Patient has known CNS metastases when initiating naxitamab treatment
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.