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Monoclonal Antibodies
177Lu-DTPA-omburtamab for Medulloblastoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Y-mAbs Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test a new treatment for children and adolescents with medullablastoma that has returned or is resistant to initial treatment. The treatment, 177Lu-DTPA-omburtamab, is a radioactive antibody that targets the protein B7-H3.
Eligible Conditions
- Medulloblastoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicities (DLTs) Part 1
Secondary outcome measures
Absorbed radiation dose of lutetium-177 in blood and cerebrospinal fluid (CSF)
Analysis of lutetium-177 activity in blood
Dosimetry analysis of lutetium-177
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 177Lu-DTPA-omburtamabExperimental Treatment1 Intervention
Intracerebroventricular administration of 177Lu-DTPA-omburtamab for up to two cycles (Part 1) and up to five cycles (Part 2).
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Who is running the clinical trial?
Y-mAbs TherapeuticsLead Sponsor
25 Previous Clinical Trials
1,555 Total Patients Enrolled
1 Trials studying Medulloblastoma
62 Patients Enrolled for Medulloblastoma
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
How old are they?
< 18
What site did they apply to?
The Royal Marsden Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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