- - Histologically confirmed diagnosis of medulloblastoma.
- - Available molecular classification according to World Health Organisation (WHO) 2016
classification, as follows:
- WNT, SHH, Group 3, or Group 4 for patients enrolled to Part 1.
- - SHH, Group 3, or Group 4 for patients enrolled to Part 2.
- - 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
- - 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.
- - 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.
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.