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Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma

StatusRecruiting
PhasePhase 1
SponsorCerenome
Started2026-08-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 2027 → Mar 2028
See other at-risk trials from Cerenome

Amendment history

2026-09-09
Study Status, Outcome Measures, Contacts/Locations v2
Recruitment opened
Sponsor changed: Plus Therapeutics → Cerenome-9 characters
WasPlus Therapeutics
NowCerenome
Primary completion pushed: 2027-03 → 2028-03
Completion pushed: 2027-03 → 2028-03
Secondary endpoints6 to 9 entries
Neuropsychologic Outcome Neuropsychologic Outcome Neuropsychologic Outcome
Study sitescontacts updated at 1 of 1 site
2026-09-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-03→2028-03
Completion date2027-03→2028-03
Start dateestimated 2025-09→confirmed 2026-08-01
Lead sponsorPlus Therapeutics→Cerenome
2025-07-10
Original filing
Cerenome
5 trials monitored
See 1 trial at risk
Glioma
666 trials monitored
See 38 trials at risk
Pediatric patients 6-21 years of age with supratentorial recurrent, refractory, or progressive pediatric ependymoma and high-grade glioma (HGG) will be included in this study of treatment with Rhenium-186 Nanoliposome (186RNL). Phase 1 of the study will look to determine the maximum tolerated dose (MTD) of 186RNL in this patient population. Phase 2 of the study will use the recommended dose determined in Phase 1 to continue to look at overall response rate and progression-free survival following 186RNL treatment.
Trial Details
NCT Number NCT07061626
Lead Sponsor Cerenome
Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago
Conditions Ependymoma, High Grade Gliomas
Enrollment 56 participants
Start Date 2026-08-01
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-11