Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05533242 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment

Study acronym: RIT in GBM
StatusTerminated
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: The remaining shelf-life of 1 component used in the manufacture of the study medication (SM) was insufficient to support further study conduct, and no additional material could be manufactured. Production of a new SM is planned for further projects.
    • Study completion date changed from estimate of Oct 2027 to Sep 28, 2026
  2. Final enrollment: 10 participants (planned 15) Show 4 more changesShow less
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Collaborators revised (2)
    • Publications: details revised at 6 of 6 entries
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Apr 2026 to Oct 2026
    • Study completion date: Apr 2026 to Oct 2027
    • Site details revised at 7 of 7 sites
    v7
  4. Primary and study completion dates: Jun 2025 to Apr 2026
    • Study description shortened, about 3 words
    v6
  5. Start date changed from estimate of Dec 2023 to Jan 22, 2024
    • Eligibility criteria shortened, about 26 words
    • Site details revised at 2 of 7 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Sep 2023 to Jun 2025v4 Show 4 more changesShow less
    • Start date: Jun 2023 to Dec 2023
    • Study sites: 5 to 7
    • Study completion date: Dec 2023 to Jun 2025
    • Eligibility criteria revised
  2. Start date: Oct 2022 to Jun 2023v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2022 to Oct 2022
    • Site details revised at 5 of 5 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Locoregional, intracavitary radioimmunotherapy (iRIT) with a newly developed radioimmunoconjugate (Lu-177 labeled 6A10-Fab-fragments) will be used to prevent or postpone tumour recurrence in patients with GBM following standard therapy . Following study objectives will be analyzed: * Determining the Maximum Tolerated Dose (MTD) * Determining safety by assessing all new neurological, hematological and other AEs CTC grade 2 or higher * Determining absorbed dose to the 2 cm shell of the resection cavity (based on a series of SPECT/CTs of the head 2h,24h,48h, 72h p.i. and on day 5-7) * Determining absorbed dose values for the kidneys, the liver, the active marrow (based on a series of SPECT/CTs of the abdomen 2h,24h,48h, 72h p.i. and on day 5-7) * Determining 24 weeks Progression-Free-Survival (PFS), defined from the day of inclusion
Trial Details
NCT Number NCT05533242
Lead Sponsor University Hospital Muenster
Collaborators: Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH), Lumara Bio Oncologics GmbH
Conditions
(from sponsor)		 Glioblastom WHO Grade 4
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov