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

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ClinicalTrials.gov Identifier: NCT06013618
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborator:
Hainan General Hospital
Information provided by (Responsible Party):
Yizhuo Zhang, Sun Yat-sen University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: Naxitamab monotherapy Drug: GM-CSF Drug: Irinotecan Drug: Temozolomide Drug: Naxitamab in combination therapy Drug: GM-CSF with combination regimen Drug: Sintilimab Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
Actual Study Start Date : June 19, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
Drug Information available for: Naxitamab

Arms and Interventions
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Arm Intervention/treatment
naxitamab and GM-CSF only
Suitable 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.
 Drug: Naxitamab monotherapy
Naxitamab is administered on days 1, 3, and 5
Other Name: hu3F8

Drug: GM-CSF
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.
Other Name: Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor
naxitamab and GM-CSF in combination with irinotecan and temozolomide
Suitable 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.
 Drug: Irinotecan
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.
Other Name: DNA topoisomerase I inhibitor

Drug: Temozolomide
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.
Other Name: Temozolomide for Injection

Drug: Naxitamab in combination therapy
Naxitamab 2.25mg/kg IV will be administered on Days 2, 4, 8 and 10.
Other Name: hu3F8

Drug: GM-CSF with combination regimen
GM-CSF 250 mcg/m2/day will be administered subcutaneously on Days 6-10.
Other Name: Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor
naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody
Suitable 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.
 Drug: Irinotecan
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.
Other Name: DNA topoisomerase I inhibitor

Drug: Temozolomide
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.
Other Name: Temozolomide for Injection

Drug: Naxitamab in combination therapy
Naxitamab 2.25mg/kg IV will be administered on Days 2, 4, 8 and 10.
Other Name: hu3F8

Drug: GM-CSF with combination regimen
GM-CSF 250 mcg/m2/day will be administered subcutaneously on Days 6-10.
Other Name: Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor

Drug: Sintilimab
Sintilimab was administerd with 3mg/kg (max 200mg) on day 11 every 3 weeks.
Other Name: PD-1 antibody


Outcome Measures
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Primary Outcome Measures :
  1. ORR [ Time Frame: from start of naxitamab treatment to 1.5 years after EOT ]
    The proportion of patients who achieved CR or PR


Secondary Outcome Measures :
  1. DCR [ Time Frame: from start of naxitamab treatment to 1.5 years after EOT ]
    The proportion of patients who achieved CR or PR or SD

  2. EFS [ Time Frame: from start of naxitamab treatment to 1.5 years after EOT ]
    The time from from start of naxitamab treatment to disease progression, recurrence

  3. OS [ Time Frame: from start of naxitamab treatment to 1.5 years after EOT ]
    The time from from start of naxitamab treatment to death or loss of follow-up


Eligibility Criteria
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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06013618


Contacts
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Contact: Yizhuo Zhang, MD 0087342460 zhangyzh@sysucc.org.cn
Contact: Juan Wang 008687342660 wangjuan@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yi-Zhuo Zhang, MD    87342460    zhangyzh@sysucc.org.cn   
Principal Investigator: Yi-Zhuo Zhang, MD         
Sponsors and Collaborators
Sun Yat-sen University
Hainan General Hospital
Investigators
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Study Chair: Yizhuo Zhang SunYat Sen University Cancer Center
More Information
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Responsible Party: Yizhuo Zhang, Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT06013618    
Other Study ID Numbers: 3F8-RWS
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Topoisomerase I Inhibitors
 Temozolomide
Molgramostim
Sargramostim
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Immunologic Factors
Physiological Effects of Drugs