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NCT05739942 · ClinicalTrials.gov registry record · Phase 1
Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma
A Phase 1 study of Newly Diagnosed and Recurrent Glioblastoma, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 20
- Study locations
NCT05739942: Active Phase 1 study of Newly Diagnosed and Recurrent Glioblastoma, sponsored by Novartis Pharmaceuticals.
NCT05739942 is a Phase 1 study of Newly Diagnosed and Recurrent Glioblastoma that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05739942, a Phase 1 study of Newly Diagnosed and Recurrent Glioblastoma, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT observation period of \[177Lu\]Lu-NeoB. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. In Group 1 (newly diagnosed GBM), the DLT observation period is defined as a total of 8 weeks (56
Conditions Studied
Interventions
- DRUG [68Ga]Ga-NeoB
- DRUG [177Lu]Lu-NeoB
- OTHER Temozolomide
Study Locations (20)
Other
- Novartis Investigative Site - Marseille
- Novartis Investigative Site - Essen
- Novartis Investigative Site - München
- Novartis Investigative Site - Rostock
- Novartis Investigative Site - Jerusalem
- Novartis Investigative Site - Porto
- Novartis Investigative Site - Barcelona
Catalonia
- Novartis Investigative Site - Badalona
- Novartis Investigative Site - Barcelona
California
- University of California LA - Los Angeles
Colorado
- University of Colorado Denver - Aurora
Florida
- Mayo Clinic Jacksonville - Jacksonville
Massachusetts
- Dana Farber Cancer Institute - Boston
New York
- Memorial Sloan Kettering Cancer Ctr - New York
Ohio
- Univ Hosp Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2032-07-01 |
| Phase | Phase 1 |
What the registry record for NCT05739942 still lists
NCT05739942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Newly Diagnosed and Recurrent Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which [68Ga]Ga-NeoB is the first listed.
NCT05739942 names 20 study sites across 13 states, led by Other, Catalonia, California.
Frequently Asked Questions
What is clinical trial NCT05739942 about?
NCT05739942 is a clinical study titled "Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma". 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 ...
What is the current status of trial NCT05739942?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-05-15. Estimated completion is 2032-07-01.
What conditions does trial NCT05739942 study?
This clinical trial studies the following conditions: Newly Diagnosed and Recurrent Glioblastoma.
What interventions are being tested in trial NCT05739942?
The interventions under investigation include: [68Ga]Ga-NeoB (DRUG), [177Lu]Lu-NeoB (DRUG), Temozolomide (OTHER).
Who is sponsoring clinical trial NCT05739942?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05739942 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05739942's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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