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NCT06379217 · ClinicalTrials.gov registry record · Phase 1
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
A Phase 1 study of Metastatic Neuroendocrine Prostate Cancer, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 11
- Study locations
NCT06379217: Active Phase 1 study of Metastatic Neuroendocrine Prostate Cancer, sponsored by Novartis Pharmaceuticals.
NCT06379217 is a Phase 1 study of Metastatic Neuroendocrine Prostate Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06379217, a Phase 1 study of Metastatic Neuroendocrine Prostate Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide Receptor (GRPR) between the baseline and following targeted radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC). Study is planning to enroll approximately 20 participants in \[177Lu\]Lu-PSMA-617 treatment arm, approximately 3 participants in \[177Lu\]Lu-NeoB treatment arm, and approximately 13 participants in \[177Lu\]Lu-DOTA-TATE treatment arm.
Primary Outcome
Number/extent of lesions with at least a moderate update of any of the RLIs according to visual assessment scoring scale on each corresponding targeted PET/CT scan based on blinded independent central review (BICR) assessment.
Conditions Studied
Interventions
- DRUG [68Ga]Ga-NeoB
- DRUG [177Lu]Lu-DOTA-TATE
- DRUG [68Ga]Ga-PSMA-11
- DRUG [68Ga]GA-DOTA-TATE
- DRUG [177Lu]Lu-PSMA-617
Study Locations (11)
Other
- Novartis Investigative Site - Nantes
- Novartis Investigative Site - München
- Novartis Investigative Site - Rostock
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - London
California
- Stanford University - Palo Alto
Nebraska
- Nebraska Cancer Specialists - Omaha
New York
- Memorial Sloan Kettering Cancer Ctr - New York
Washington
- Seattle Cancer Care Alliance - Seattle
Barcelona
- Novartis Investigative Site - L'Hospitalet de Llobregat
Surrey
- Novartis Investigative Site - Sutton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2024-07-29 |
| Est. Completion | 2026-08-27 |
| Phase | Phase 1 |
What the registry record for NCT06379217 still lists
NCT06379217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Metastatic Neuroendocrine Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which [68Ga]Ga-NeoB is the first listed.
NCT06379217 lists 11 locations in 7 states (Other, California, Nebraska).
Frequently Asked Questions
What is clinical trial NCT06379217 about?
NCT06379217 is a clinical study titled "NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.". The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide Receptor (GRPR) between the baseline and following targeted radioligand ...
What is the current status of trial NCT06379217?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2024-07-29. Estimated completion is 2026-08-27.
What conditions does trial NCT06379217 study?
This clinical trial studies the following conditions: Metastatic Neuroendocrine Prostate Cancer.
What interventions are being tested in trial NCT06379217?
The interventions under investigation include: [68Ga]Ga-NeoB (DRUG), [177Lu]Lu-DOTA-TATE (DRUG), [68Ga]Ga-PSMA-11 (DRUG), [68Ga]GA-DOTA-TATE (DRUG), [177Lu]Lu-PSMA-617 (DRUG).
Who is sponsoring clinical trial NCT06379217?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06379217 being conducted?
This trial has 11 study locations across California, Nebraska, New York, Washington, Barcelona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06379217's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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