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Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion moved earlier from Nov 8, 2028 to Aug 10, 2027 Eligibility criteria shortened, about 29 words · Secondary endpoints: details revised at 11 of 12 entries · Study description expanded, about 2 words Show 3 more changesShow less
    • Eligibility criteria shortened, about 29 words
    • Secondary endpoints: details revised at 11 of 12 entries
    • Study description expanded, about 2 words
  2. Primary completion pushed from Dec 10, 2026 to Nov 8, 2028 Trial sites reduced: 23 → 16 locations · Completion moved earlier from Jul 1, 2032 to Nov 8, 2028 · Enrollment target: 40 to 42 · 1 morev27 Show 4 more changesShow less
    • Trial sites reduced: 23 → 16 locations
    • Completion moved earlier from Jul 1, 2032 to Nov 8, 2028
    • Enrollment target: 40 to 42
    • Study description expanded, about 119 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 3 of 23 sitesv26
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 48 to confirmed 40 · Site details revised at 23 of 23 sitesv25 Show 2 more changesShow less
    • Enrollment target: estimated 48 to confirmed 40
    • Site details revised at 23 of 23 sites
  5. Site details revised at 3 of 23 sitesv24
Show 22 earlier versionsHide 22 earlier versions
  1. Primary completion date: Feb 5, 2026 to Dec 10, 2026 Completion date: Aug 28, 2031 to Jul 1, 2032 · Site details revised at 3 of 23 sitesv23 Show 2 more changesShow less
    • Completion date: Aug 28, 2031 to Jul 1, 2032
    • Site details revised at 3 of 23 sites
  2. Study sites: 22 to 23v22
  3. Study sites: 20 to 22v21
  4. Study sites: 19 to 20v20
  5. Study sites: 16 to 19v19
  6. Study sites: 15 to 16v18
  7. Study sites: 11 to 15v17
  8. Secondary endpoints revised (12) Eligibility criteria shortened, about 4 wordsv16 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 8 to 11 Primary completion date: May 4, 2026 to Feb 5, 2026 · Completion date: Jun 1, 2026 to Aug 28, 2031v15 Show 2 more changesShow less
    • Primary completion date: May 4, 2026 to Feb 5, 2026
    • Completion date: Jun 1, 2026 to Aug 28, 2031
  10. Study sites: 7 to 8v14
  11. Study sites: 6 to 7v13
  12. Study sites: 4 to 6v12
  13. Start date changed from estimate of May 1, 2024 to May 15, 2024v11
  14. Study sites: 3 to 4v10
  15. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 31, 2025 to May 4, 2026 · Start date: Apr 1, 2024 to May 1, 2024 · Study sites: 0 to 3 · 1 morev9 Show 4 more changesShow less
    • Primary completion date: Oct 31, 2025 to May 4, 2026
    • Start date: Apr 1, 2024 to May 1, 2024
    • Study sites: 0 to 3
    • Completion date: Nov 28, 2025 to Jun 1, 2026
  16. Start date: Jan 4, 2024 to Apr 1, 2024 Primary completion date: Aug 6, 2025 to Oct 31, 2025 · Completion date: Sep 3, 2025 to Nov 28, 2025v8 Show 2 more changesShow less
    • Primary completion date: Aug 6, 2025 to Oct 31, 2025
    • Completion date: Sep 3, 2025 to Nov 28, 2025
  17. Primary completion date: Oct 30, 2025 to Aug 6, 2025 Completion date: Dec 31, 2025 to Sep 3, 2025 · Start date: Apr 1, 2024 to Jan 4, 2024 · Eligibility criteria expanded, about 530 words · 2 morev7 Show 5 more changesShow less
    • Completion date: Dec 31, 2025 to Sep 3, 2025
    • Start date: Apr 1, 2024 to Jan 4, 2024
    • Eligibility criteria expanded, about 530 words
    • Secondary endpoints revised (12)
    • Study description shortened, about 105 words

    See this version in full on ClinicalTrials.gov ↗

  18. Primary endpoints: 2 to 1 Eligibility criteria expanded, about 152 words · Secondary endpoints: 11 to 12 · Study description expanded, about 160 words · 2 morev6 Show 5 more changesShow less
    • Eligibility criteria expanded, about 152 words
    • Secondary endpoints: 11 to 12
    • Study description expanded, about 160 words
    • Study arms: 1 to 2
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  19. Primary completion date: Dec 20, 2024 to Oct 30, 2025 Start date: Aug 24, 2023 to Apr 1, 2024 · Completion date: Jan 17, 2025 to Dec 31, 2025v5 Show 2 more changesShow less
    • Start date: Aug 24, 2023 to Apr 1, 2024
    • Completion date: Jan 17, 2025 to Dec 31, 2025
  20. Enrollment target: 42 to 48v4
  21. 2 versions Re-verified since Mar 2, 2023, no change to tracked fieldsv2-v3
  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.
Novartis
555 trials monitored
See 31 trials at risk
Glioblastoma
670 trials monitored
See 44 trials at risk
This study will investigate different doses of \[177Lu\]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed glioblastoma, with methylated or unmethylated promoter, to assess the safety and efficacy of \[177Lu\]Lu-NeoB in combination with the SoC and in recurrent glioblastoma as single agent, to identify the recommended dose and to also explore the safety of the PET imaging agent \[68Ga\]Ga-NeoB and characterize its uptake in the tumor area.
Trial Details
NCT Number NCT05739942
Lead Sponsor Novartis Pharmaceuticals
Conditions Newly Diagnosed and Recurrent Glioblastoma
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov