Clinical Trials Logo

Clinical Trial Summary

Omburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7- H3). Omburtamab is 131I-labeled at designated radio pharmacies and will be provided as a final radiolabeled product to treatment site. The proposed intervention includes surgical placement using standard stereotactic techniques of a small caliber cannula into the tumor in the pons followed by positive pressure infusion (i.e. CED) of 131I-omburtamab. Iodine-131 conjugated omburtamab (131I-omburtamab) administered via the intracerebroventricular route for the treatment of metastatic CNS neuroblastoma was shown to be tolerable and improve survival. Furthermore, 124I-omburtamab administered by convection enhanced delivery (CED) was shown to have a tolerable safety profile in an ongoing dose escalation trial (in doses up to 4mCi) in patients with diffuse pontine gliomas that have not progressed following external beam radiation therapy. The aim of this trial is to determine the efficacy and safety of 131I-omburtamab in patients with DIPG that have not progressed following external beam radiation therapy.


Clinical Trial Description

The IMP infusion volume for CED will be adjusted to 4, 6 or 8 mL dependent on the size of the tumor as estimated by MRI. The maximum volume of 8 mL was tested, and safety cleared in the 11-011 trial. Assuming a ratio of approximately 1:3 between the infusion volume and the distribution volume the infusion volume will be adjusted to ensure coverage of the tumor and 0.5 cm of the surrounding margin. The infusion volume will be 4 mL if tumor size (+0.5 cm margin) <10 cm3, 6 mL if tumor size (+0.5 cm margin) ≥10 and <15 cm3, and 8 mL if tumor size (+0.5 cm margin) ≥15 and ≤20 cm3. The maximum infusion rate will be 10 μL/min. Infusions will be initiated using an escalating flow rate plan with 10-min intervals until the maximum rate is achieved (0·5 μL/min, 1·0 μL/min, 2·0 μL/min, 5·0 μL/min, 7·5 μL/min and 10 μL/min). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05063357
Study type Interventional
Source Y-mAbs Therapeutics
Contact Rana Abdelhamid
Phone 646-885-8477
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date December 2021
Completion date January 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT01837862 - A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas Phase 1/Phase 2
Recruiting NCT04295759 - INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas Phase 1
Recruiting NCT04670016 - HRQL and Symptom Assessment for Patients With DIPG or Recurrent and Re-irradiated Brain Tumours and Their Caregivers
Recruiting NCT04250064 - A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma Phase 2
Terminated NCT02758366 - Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma Phase 2
Active, not recruiting NCT01952769 - Anti PD1 Antibody in Diffuse Intrinsic Pontine Glioma Phase 1/Phase 2
Recruiting NCT03478462 - Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma Phase 1