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

ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorSun Yat-Sen University Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: naxitamab and GM-CSF onlyOther 2 interventions
Group B: naxitamab and GM-CSF in combination with irinotecan and temozolomideOther 4 interventions
Group C: naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibodyOther 5 interventions

Trial outcomes

Primary outcomes

1

ORR

The proportion of patients who achieved CR or PR

Time frame
from start of naxitamab treatment to 1.5 years after EOT

Secondary outcomes

1

DCR

The proportion of patients who achieved CR or PR or SD

Time frame
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

Time frame
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

Time frame
from start of naxitamab treatment to 1.5 years after EOT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen University Cancer Center

Lead sponsor

Hainan General Hospital

Collaborator

Source ClinicalTrials.gov
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