A Phase I Trial Of The Humanized Anti-GD2 Antibody (HU14.18K322A) In Children And Adolescents With Neuroblastoma, Osteosarcoma Or Melanoma
SJGD2 is Phase I dose finding study. The primary purpose of this phase I study is to
determine maximum tolerated dose (MTD) and dose-limiting toxicity of two schedules (daily x
4 or weekly x 4) of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research
participants with neuroblastoma or melanoma.
Initially, one research participant will be treated at the lowest dose level and if no
toxicity is observed then the next participant will be treated at the next dose level. This
is continued until the first instance of biological activity (in the form of grade 2 side
effects) is observed and from that point on a traditional phase I study design will be
Secondary objectives include:
1. Estimate the response rate, within the confines of a phase I study, to the humanized
anti-GD2 antibody, hu14.18K322A.
2. Evaluate the pharmacokinetics of hu14.18K322A.
3. Examine whether or not human anti-human antibodies (HAHA) develop in participants
4. Assess the tolerability of the hu14.18K322A at the MTD of the daily x4 and the weekly
dosing in patients with refractory or recurrent osteosarcoma.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine maximum tolerated dose and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma, osteosarcoma or melanoma.
Fariba Navid, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|