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An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer

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Trial Profile

An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2025

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At a glance

  • Drugs Lutetium 177 rhPSMA (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Blue Earth Therapeutics

Most Recent Events

  • 07 Oct 2025 According to a Blue Earth Therapeutics media release, Phase 1 patient data were used to develop modeling results that have informed the design of the Phase 2 portion of the Phase 1/2 clinical trial.
  • 25 Jun 2025 According to a Blue Earth Therapeutics media release, Phase 2 part of this study is ongoing and is evaluating the impact of administering a greater proportion of radioactivity than the phase 1 part.
  • 25 Jun 2025 According to a Blue Earth Therapeutics media release, radiation dosimetry results from phase 1 part of this study were presented at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, by Professor James Nagarajah of Radboud University Medical Centre, the Netherlands.

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