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NCT05413850 · ClinicalTrials.gov registry record · Phase 1
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
A Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Blue Earth Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
- 19
- Study locations
NCT05413850: Recruiting Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Blue Earth Therapeutics.
NCT05413850 is a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Blue Earth Therapeutics. The registered enrollment target is 82 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 19 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05413850, a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Blue Earth Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
- 19
- Study locations
Study Summary
To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Primary Outcome
Incidence of DLTs during the DLT observation period.
Conditions Studied
Interventions
- DRUG Lutetium (177Lu) rhPSMA-10.1 Injection
- DIAGNOSTIC_TEST 18F-rhPSMA-7.3 injection (in phase 1 only)
Study Locations (19)
Other
- Jules Bordet Institute - Brussels
- Saint Luc University Hospital - Brussels
- University Hospital Ghent - Ghent
- University Hospital Leuven - Leuven
- University Hospital Center Sart-Tilman - Liège
- University Hospital Essen - Essen
- Hospital Rechts der Isar - Munich
- Meander Medisch Centrum - Amersfoort
- Bristol Hematology and Oncology Center - Bristol
- Beatson West of Scotland Cancer Center - Glasgow
- St Bartholomew's Hospital - London
- James Cook University Hospital - Middlesbrough
- Weston Park - Sheffield
- University Hospital Southampton NHS Foundation Trust - Southampton
Florida
- Biogenix Molecular LLC - Miami
Georgia
- Emory University Hospital - Atlanta
Nebraska
- XCancer Omaha / Urology Cancer Center - Omaha
New York
- Weill Cornell Medicine - New York - Presbyterian Hospital - New York
Gelderland
- Radboud UMC - Nijmegen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 1 |
What NCT05413850 shows while recruiting
NCT05413850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower).
The record links to 6 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Lutetium (177Lu) rhPSMA-10.1 Injection is the first listed.
NCT05413850 lists 19 locations in 6 states (Other, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT05413850 about?
NCT05413850 is a clinical study titled "Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection". To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
What is the current status of trial NCT05413850?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2022-07-20. Estimated completion is 2028-03-31.
What conditions does trial NCT05413850 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Prostatic Neoplasms, Urogenital Neoplasms, Prostatic Diseases.
What interventions are being tested in trial NCT05413850?
The interventions under investigation include: Lutetium (177Lu) rhPSMA-10.1 Injection (DRUG), 18F-rhPSMA-7.3 injection (in phase 1 only) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05413850?
This trial is sponsored by Blue Earth Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05413850 being conducted?
This trial has 19 study locations across Florida, Georgia, Nebraska, New York, Gelderland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05413850's enrollment target sits among peer trials
82 367th of 735 higher than 368 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
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