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NeuroblastomaPhase 2NCT06013618

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

A Phase 2 study testing Naxitamab monotherapy, GM-CSF and Irinotecan in people with Neuroblastoma, run by Sun Yat-Sen University Cancer Center at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 more about this study

Who is it for?
Ages 12 months and older
Conditions the study is for
Neuroblastoma
What is being tested?
Naxitamab monotherapy, GM-CSF and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
19 Jun 2023to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 interventional 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 physician
Show all 12Show fewer
  • 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 these assessments are clinically indicated
  • Applicable for treatment with naxitamab in combination with GM-CSF only:
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yizhuo Zhang, MD contact

0087342460

zhangyzh@sysucc.org.cn

Juan Wang contact

008687342660

wangjuan@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Yi-Zhuo Zhang, MD, 87342460, zhangyzh@sysucc.org.cn

    Yi-Zhuo Zhang, MD

    Recruiting

Other trials in China

About this study

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 the detailed description

Patients with high risk neuroblastoma who obtain CR after chemotherapy combined with surgery, radiotherapy and/or hematopoietic stem cell transplantation received axitamab and GM-CSF. Patients with high-risk neuroblastoma treated by chemotherapy combined with surgery, radiotherapy and or hematopoietic stem cell transplantation patients with tumor residual or progression during treatment (refractory) received naxitamab and GM-CSF in combination with irinotecan and temozolomide or naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody.

Conditions
Neuroblastoma
Being tested
Naxitamab monotherapy, GM-CSF, Irinotecan, Temozolomide, Naxitamab in combination therapy
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naxitamab monotherapyDrug

    Also called hu3F8

    Naxitamab is administered on days 1, 3, and 5

  • GM-CSFDrug

    Also called Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor

    Each treatment cycle is 28 days and is started with five days (days -4 to 0) of GM-CSF administered at 250 mcg/m2/day in advance of the start of naxitamab infusion. GM-CSF is thereafter administered at 500 mcg/m2/day on days 1 to 5.

  • IrinotecanDrug

    Also called DNA topoisomerase I inhibitor

    Each HITS treatment cycle is 21 days. Irinotecan intravenously (IV) at 50 mg/m2/day will be administered from Day 1-5 concurrently with temozolomide orally at 150 mg/m2/day or 100 mg/m2/day.

  • TemozolomideDrug

    Also called Temozolomide for Injection

    Each HITS treatment cycle is 21 days. Irinotecan intravenously (IV) at 50 mg/m2/day will be administered from Day 1-5 concurrently with temozolomide orally at 150 mg/m2/day or 100 mg/m2/day.

  • Naxitamab in combination therapyDrug

    Also called hu3F8

    Naxitamab 2.25mg/kg IV will be administered on Days 2, 4, 8 and 10.

  • GM-CSF with combination regimenDrug

    Also called Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor

    GM-CSF 250 mcg/m2/day will be administered subcutaneously on Days 6-10.

  • SintilimabDrug

    Also called PD-1 antibody

    Sintilimab was administerd with 3mg/kg (max 200mg) on day 11 every 3 weeks.

Study groups in NCT06013618
Study groupRoleWhat they receive
naxitamab and GM-CSF onlyOtherSuitable for patients with high risk neuroblastoma who obtain CR after chemotherapy combined with surgery, radiotherapy and/or hematopoietic stem cell transplantation. The treatment cycle is repeated every 4 weeks for a total of 5 courses, and discontinuation of nasetuzumab and GM-CSF should be considered if disease progression or unacceptable toxicity occurs.
Receives: Drug: Naxitamab monotherapy; Drug: GM-CSF
naxitamab and GM-CSF in combination with irinotecan and temozolomideOtherSuitable for high-risk group neuroblastoma treated by chemotherapy combined with surgery, radiotherapy and or hematopoietic stem cell transplantation patients with tumor residual or progression during treatment (refractory); Patients who relapse after initial treatment. Repeat every 3 weeks until tumor progression, patient withdrawal, or toxicity becomes intolerable, up to 8 procedures.
Receives: Drug: Irinotecan; Drug: Temozolomide; Drug: Naxitamab in combination therapy; Drug: GM-CSF with combination regimen
naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibodyOtherSuitable for high-risk group neuroblastoma treated by chemotherapy combined with surgery, radiotherapy and or hematopoietic stem cell transplantation patients with tumor residual or progression during treatment (refractory); Patients who relapse after initial treatment. Repeat every 3 weeks until tumor progression, patient withdrawal, or toxicity becomes intolerable, up to 8 procedures.
Receives: Drug: Irinotecan; Drug: Temozolomide; Drug: Naxitamab in combination therapy; Drug: GM-CSF with combination regimen; Drug: Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    The proportion of patients who achieved CR or PR

    Measured: from start of naxitamab treatment to 1.5 years after EOT

Secondary outcomes (3)

  1. DCR

    The proportion of patients who achieved CR or PR or SD

    Measured: from start of naxitamab treatment to 1.5 years after EOT

  2. EFS

    The time from from start of naxitamab treatment to disease progression, recurrence

    Measured: from start of naxitamab treatment to 1.5 years after EOT

  3. OS

    The time from from start of naxitamab treatment to death or loss of follow-up

    Measured: from start of naxitamab treatment to 1.5 years after EOT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start19 Jun 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06013618
Sponsor's protocol ID
3F8-RWS
Status last verified
Jun 2025
First submitted
19 Aug 2023
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naxitamab monotherapy, GM-CSF and Irinotecan in people with Neuroblastoma, run by Sun Yat-Sen University Cancer Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yizhuo Zhang, MD (0087342460, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: from start of naxitamab treatment to 1.5 years after EOT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06013618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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