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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: 26 May 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

  • 01 May 2025 According to a Blue Earth Therapeutics media release, study design aligns with the US FDA Project Optimus initiative where the goal is that drug developers optimize dosing early in a product's development to deliver the best possible benefit risk profile.
  • 01 May 2025 According to a Blue Earth Therapeutics media release, the first study results from this trial could be available as soon as H1 2026. The first patients have received doses of (177Lu) rhPSMA-10.1 injection.
  • 17 Mar 2025 Timeframe for primary endpoint antitumor response changed from 12 weekly intervals to 6 weekly intervals

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