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Recruiting Phase 2Phase 3 Interventional

A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients

ClinicalTrials.gov ID: NCT07549321

Public ClinicalTrials.gov record NCT07549321. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 12:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination With Chemotherapy in Participants With High-Risk Neuroblastoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years. Most patients have 'high-risk' disease, with spread of the disease to different sites (metastases). This multinational study aims to find out how effective and safe the treatment of a monoclonal anti-GD2 antibody hu14.18K322A (daretabart) is when used together with chemotherapy to treat children and young people who have high-risk neuroblastoma.

Study identification

NCT ID
NCT07549321
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Renaissance Pharma Ltd.
Industry
Enrollment
144 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Months to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 29, 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031
Last update posted
Aug 13, 2026

2026 – 2031

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Children's Hospital Colorado Anschutz Medical Aurora Colorado 80045 Recruiting
University of Minnesota Masonic Children's Hospital Minneapolis Minnesota 55454 Recruiting
The Children's Hospital at Montefiore The Bronx New York 10467 Recruiting
Duke University Medical Center Durham North Carolina 27705 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07549321, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07549321 live on ClinicalTrials.gov.

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