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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Renaissance Pharma Ltd.
Study ID
NCT07549321
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 24, 2026
Start date
Mar 30, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Higher dose
  • Other: Lower dose

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Assessed at end of treatment (up to 12 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado Anschutz MedicalAuroraColorado80045
Navin Pinto MD, MD
[email protected]
720-777-8134
University of Minnesota Masonic Children's HospitalMinneapolisMinnesota55454
Robin Williams, MD
[email protected]
612-626-2778
The Children's Hospital at MontefioreThe BronxNew York10467
Alice Lee, MD
[email protected]
718-741-2342
Duke University Medical CenterDurhamNorth Carolina27705
Jessica Sun, MD
[email protected]
919-684-3401
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Rochelle Bagatell MD
[email protected]
+1 (215) 590-2299

Find similar trials in Aurora, CO

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's Hospital Colorado Anschutz Medical· Aurora, COUniversity of Minnesota Masonic Children's Hospital· Minneapolis, MNThe Children's Hospital at Montefiore· The Bronx, NYDuke University Medical Center· Durham, NCChildren's Hospital of Philadelphia· Philadelphia, PA

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