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NCT05739942

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

Active, enrolled Phase 1 Last updated 3 February 2026
What this trial tests

Phase 1 trial testing [177Lu]Lu-NeoB in Newly Diagnosed and Recurrent Glioblastoma in 42 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
15 May 2024
Primary endpoint
10 December 2026
8 November 2028

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 1
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment42
Start date15 May 2024
Primary completion10 December 2026
Estimated completion8 November 2028
Sites23 locations across Portugal, United States, Germany, Spain, Italy, France

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Newly Diagnosed and Recurrent Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting epigenetic regulators as a promising avenue to overcome cancer therapy resistance.
    Song J, Yang P, Chen C, Ding W, et al · · 2025 · cited 40× · PMID 40675967 · DOI 10.1038/s41392-025-02266-z
  2. PET imaging of gliomas: Status quo and quo vadis?
    Galldiks N, Lohmann P, Friedrich M, Werner JM, et al · · 2024 · cited 21× · PMID 38970818 · DOI 10.1093/neuonc/noae078
  3. Side-by-side comparison of the two widely studied GRPR radiotracers, radiolabeled NeoB and RM2, in a preclinical setting.
    Damiana TST, Paraïso P, de Ridder C, Stuurman D, et al · · 2023 · cited 12× · PMID 37584725 · DOI 10.1007/s00259-023-06364-4
  4. Radioligand Therapy in Cancer Management: A Global Perspective.
    Ninatti G, Lee ST, Scott AM. · · 2025 · cited 5× · PMID 41228206 · DOI 10.3390/cancers17213412
  5. Emerging PET Imaging Agents and Targeted Radioligand Therapy: A Review of Clinical Applications and Trials.
    Palihati M, Das JP, Yeh R, Capaccione K. · · 2025 · cited 5× · PMID 40863874 · DOI 10.3390/tomography11080083
  6. Innovative radiotherapies for the treatment of glioblastoma.
    Van Eupen L, Waked A, Primac I, Vermeulen K, et al · · 2026 · PMID 41684714 · DOI 10.1093/noajnl/vdaf255

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing