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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 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.

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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.

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

FieldValue
Enrollment Target 82 participants
Start Date 2022-07-20
Est. Completion 2028-03-31
Phase Phase 1

Sponsor

Blue Earth Therapeutics

2 total trials

What the Registry Record Tells You About NCT05413850

The ClinicalTrials.gov registry entry for NCT05413850 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The listed sponsor is Blue Earth Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 19 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.