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Clinical Trial 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.


Clinical Trial Description

This is an interventional, non-randomised, open-label, integrated Phase 1 & 2 study to assess the safety, radiation dosing regimen and anti-tumour activity of Lutetium (177Lu) rhPSMA-10.1 (Tx IMP) in men with metastatic castrate-resistant prostate cancer (mCRPC). The study will consist of 2 parts: a Phase 1, with safety, dose-finding, and dosimetry components, and a Phase 2, with assessment of efficacy and safety utilising the dose selected from Phase 1. Both phases will include subjects with prostate-specific membrane antigen (PSMA)-positive mCRPC as detected using 18F-rhPSMA-7.3 diagnostic IMP. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05413850
Study type Interventional
Source Blue Earth Therapeutics Ltd
Contact Blue Earth Therapeutics
Phone +44 (0)1865 634500
Email contact@blueearthTx.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 20, 2022
Completion date October 27, 2026

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