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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: 10 Mar 2026

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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

  • 15 Jan 2026 According to a Blue Earth Therapeutics media release, first patients in the UK have been administered in Phase II part with the investigational drug at St Bartholomew's Hospital and The James Cook University Hospital.
  • 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.

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