An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma

Sponsor
Princess Maxima Center for Pediatric Oncology
Study ID
NCT07399821
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • anti-GD2-800CW — DRUG
    Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery. In phase Ib, using a 3+3 design, a dose escalation is performed to determine the RP2D.

Study Details

This is a non-randomized, open label phase Ib/II dose-escalation and expansion study designed to define the recommended dose of anti-GD2-800CW in pediatric neuroblastoma patients. The aim of this imaging study is to determine a safe and effective dose of anti-GD2-800CW for intra-operative detection of neuroblastoma using NIR fluorescence.

Key Dates

Start date
Nov 5, 2025
Status verified
Nov 2025
Primary completion
Apr 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: anti-GD2-800CW
    Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery.

Primary Outcome Measure

To establish the recommended phase 2 dose (RP2D), based on efficacy and safety, of the anti-GD2-800CW fluorescent imaging agent in pediatric patients with neuroblastoma. [ Time Frame: Through escalation phase completion, an average of 1 year. ]

Central Contacts

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