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Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG

StatusActive, Not Recruiting
PhasePhase 1
Started2023-10-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 13 months later May 2026 → Jun 30, 2027
See other at-risk trials from Cellectar Biosciences, Inc.

Amendment history

2026-10-02
Primary completion pushed: 2026-05 → 2027-06-30
Completion pushed: 2026-09 → 2027-12
2026-03-16
Study Status, IPDSharing v8
Re-verified, no change to tracked fields
2025-03-25
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 8 of 8 sites
2024-07-05
Study Status, Contacts/Locations v6
Study sitesdetails revised at 3 of 8 sites
2024-05-15
Study Status, Contacts/Locations v5
Study sitesdetails revised at 3 of 8 sites
Show 4 earlier versions
2023-12-05
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sites3→8
Eligibility criteria+125 characters
[...] aphically suspected to be relapsed, refractory, or recurrent for which there are no standard treatment options with curative potential ≥ 210 years of age and ≤ 25 years of age at time of consent/assen [...] and dosing) Absolute neutrophil count ≥ 750/μL Hemoglobin ≥ 108 g/dL (last transfusion must be at least 1 week prior to stu [...] 73m2 Alanine aminotransferase < 3 × ULN Bilirubin < 2 × ULN PatientsAt enrollingleast 1 measurable intracranial lesion with longest diameter of at totalleast 10 mm on any imaging sequence. ⇅ moved Patients with previously known neurological deficits must be clinically stable at time o [...] [...]
Secondary endpointsdetails revised at 3 of 4 entries
Primary endpoints3 to 2 entries
Efficacy Evaluation for Overall Survival
2023-08-26
Study Status v3
Start date2023-05→2023-10-01
2023-05-16
Study Status v2
Re-verified, no change to tracked fields
2023-02-07
Study Status v1
Primary completion date2026-09→2026-05
Completion date2026-12→2026-09
Start date2022-11→2023-05
2022-11-03
Original filing
The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).
Trial Details
NCT Number NCT05610891
Lead Sponsor Cellectar Biosciences, Inc.
Collaborators: National Cancer Institute (NCI)
Conditions High-Grade Glioma
Enrollment 50 participants
Start Date 2023-10-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-10-01