Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma

Sponsor
Y-mAbs Therapeutics
Study ID
NCT04560166
Phase
PHASE2
Status
Terminated

Conditions

  • Neuroblastoma Recurrent

Eligibility Criteria

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

Interventions

  • Naxitamab and GM-CSF in combination with irinotecan and temozolomide — DRUG
    * Irinotecan, solution for infusion (20 mg/mL) * Temozolomide, capsules (5 mg, 20 mg and 100 mg) * The humanized immunoglobulin isotype G (IgG1) monoclonal antibody (mAb) naxitamab, solution for infusion (4 mg/mL) * Sargramostim (GM-CSF), lyophilized 250 µg single use vial (250 µg/vial)

Study Details

An International, Single-Arm, Multicenter Phase 2 Trial.

Key Dates

Start date
Nov 8, 2021
Status verified
Feb 2024
Primary completion
Sep 21, 2022
Completion
Sep 21, 2022

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Naxitamab and GM-CSF in combination with irinotecan and temozolomide
    A treatment cycle is 21 days. The patients will receive irinotecan 50 mg/m2/day IV and temozolomide 100 mg/m2/day orally (both on Days 1-5) in combination with naxitamab 2.25 mg/kg/day IV (Days 2, 4, 8 and 10) (total 9 mg/kg per cycle), and GM-CSF 250 ug/m2/day sc, (Days 6-10). Patients will receive up to 18 IT cycles after enrollment. Naxitamab and GM-CSF will be given for at least 8 cycles.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 84 days ]

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