This study will consist of four groups with the initial three groups undergoing dose escalation and the fourth group will be to confirm the optimal dose and imaging conditions.
A Phase 1, single centre, open-label study of TLX592 to assess the safety and tolerability, pharmacokinetics, biodistribution and radiation dosimetry in patients diagnosed with prostate cancer.
To be considered for the study you must meet the following criteria:
- Signed informed consent
- Biochemically recurrent, metastatic or locally advanced prostate cancer (Histologically or cytologically confirmed diagnosis)
- PSMA- Positive for prostate adenocarcinoma on a 68Ga-PSMA scan within the last month
- ECOG performance status 0-1
- Normal Organ function and marrow reserve
This research study will be examining a new product for identifying and in the future potentially treating prostate cancer. This new product targets PSMA on tumour cells. The product is an antibody-based pharmaceutical and is called 64Cu-TLX592 (or TLX592). 64Cu-TLX592 is an antibody which has been specifically designed to clear rapidly from your bloodstream. As a result of more rapid clearance from the bloodstream, 64Cu-TLX592 is expected to have less uptake in key organs, which may help develop new therapies with improved safety while maintaining the anti-cancer effects.
The aim of this study is to determine the effect of three different increasing doses on the biodistribution and pharmacokinetics of 64Cu-TLX592 – which will assist in evaluating any potential risks associated with this new pharmaceutical.