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

• Status: Recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Y-mAbs Therapeutics
• Treatments: Pentetic Acid

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of medulloblastoma.

• SHH, Group 3, or Group 4 according to World Health Organisation (WHO) 2016 classification.

• Recurrent (maximum of 2 recurrences for Part 1 and 1 recurrence for Part 2) or refractory to frontline therapy. Prior frontline or second line therapy may involve surgery, craniospinal irradiation, stereotactic radiosurgery, and multi-agent chemotherapy regimens.

• Be in cytological or radiographic remission, have residual disease, multifocal recurrent disease, or pure leptomeningeal disease.

• Performance status score of 50 to 100 on Lansky (less than 16 years) or Karnofsky (16 years or older) scales.

• Life expectancy of at least 3 months, as judged by the Investigator.

• Acceptable hematological status and liver and kidney function.

Exclusion Criteria:

• Obstructive or symptomatic communicating hydrocephalus as determined by Ommaya patency/cerebrospinal fluid (CSF) flow study.

• Residual disease (nodular or linear) measuring > 5 mm in the smallest diameter.

• Ventriculoperitoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts.

• Grade 4 neurotoxicity. Grade 3 or lower stable neurological deficits (due to brain tumor) or hearing loss are allowed.

• Uncontrolled life-threatening infection.

• Received radiation therapy less than 3 weeks prior to the screening visit.

• Received systemic or intrathecal cytotoxic chemotherapy or intrathecal immunotherapy (corticosteroids not included) less than 3 weeks prior to the screening visit.

• Received any prior anti-B7-H3 treatment.

• Non-hematologic organ toxicity Grade 3 or above; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity.

• Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.