Phase 1 Trial of 177Lu-DTPA-Omburtamab for Children and Adolescents Ages 3 to 21 With Recurrent or Resistant Brain Tumors or CNS Metastases

What this Trial Is About

Researchers are evaluating the safety of 177Lu-DPTA-omburtamab treatment in children and adolescents aged 3 to 21 who have recurrent or resistant brain tumors such as medulloblastoma or cancers that have spread to the central nervous system. This phase 1 study focuses on patients whose tumors express B7-H3 and who have already undergone conventional therapies or have no standard treatment options. The study aims to determine the maximum tolerated dose and monitor any toxicities associated with this treatment. Participants receive one of four escalating doses of 177Lu-DPTA-omburtamab ranging from 25 mCi to 100 mCi, assigned sequentially based on the dose escalation design. The treatment is given in up to two cycles, each lasting 28 days. Patients must have an intraventricular access device and may have active malignancy outside the CNS but without immediate need for systemic treatment. Some patients with systemic and CNS disease receive only one dose, while others with CNS metastases without systemic disease may receive two doses. Throughout the study, participants are closely monitored for toxicities and dose tolerance during treatment cycles. Assessments include performance status evaluations, laboratory tests for kidney and liver function, and monitoring of neurological status. Human Anti-Mouse Antibody testing is performed before treatment. The total duration of active treatment is up to two 28-day cycles, with safety outcomes recorded during this period. The study is conducted by Memorial Sloan Kettering Cancer Center and is expected to complete by July 2030.

A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)