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

Sponsor
Sun Yat-Sen University Cancer Center
Study ID
NCT06013618
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Naxitamab monotherapy — DRUG
    Naxitamab is administered on days 1, 3, and 5
  • GM-CSF — DRUG
    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.
  • Irinotecan — DRUG
    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.
  • Temozolomide — DRUG
    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 therapy — DRUG
    Naxitamab 2.25mg/kg IV will be administered on Days 2, 4, 8 and 10.
  • GM-CSF with combination regimen — DRUG
    GM-CSF 250 mcg/m2/day will be administered subcutaneously on Days 6-10.
  • Sintilimab — DRUG
    Sintilimab was administerd with 3mg/kg (max 200mg) on day 11 every 3 weeks.

Study Details

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.

Key Dates

Start date
Jun 19, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: 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.
  • Other: 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.
  • Other: 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.

Primary Outcome Measure

ORR [ Time Frame: from start of naxitamab treatment to 1.5 years after EOT ]

Central Contacts

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