NCT04167618

177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma

A Phase I/II Dose-escalation and Expansion Cohort Trial of Intracerebroventricular Radioimmunotherapy Using 177Lu-DTPA-Omburtamab in Pediatric and Adolescent Patients With Recurrent or Refractory Medulloblastoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Y-mAbs Therapeutics · Industry
• Sex: All
• Age: 3 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

Children and adolescents diagnosed with medullablastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.

Detailed description

Part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of two 5-week cycles of treatment doses of intracerebroventricular 177Lu-DTPA-omburtamab. Part 2 is a cohort-expansion phase in which patients will receive a maximum of five 5-week cycles of intracerebroventricular 177Lu-DTPA-omburtamab at the recommended dose determined in Part 1. End of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. The patients will be followed for up to 2 years after last dose.

Conditions

• Medulloblastoma, Childhood

Interventions

Type	Name	Description
DRUG	177Lu-DTPA-omburtamab	Biological, radiolabeled DPTA-omburtamab

Timeline

• Start date: 2021-09-30
• Primary completion: 2022-08-11
• Completion: 2022-08-11
• First posted: 2019-11-19
• Last updated: 2023-10-06
• Results posted: 2023-10-06

Locations

10 sites across 5 countries: United States, Denmark, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study