SECuRE Trial Continues Unchanged After Positive Safety Review
Clarity Pharmaceuticals (ASX: CU6) confirmed that the SECuRE trial will continue without any modifications following an interim review by the independent Safety Review Committee. The assessment covered evaluable data from nine participants enrolled in the Cohort Expansion Phase (Phase II) as of 25 November 2025.
The review showed a favourable safety profile for 67Cu-SAR-bisPSMA, with most treatment-related adverse events reported as Grade 1 or 2. Nausea and lymphopenia were the most common adverse events observed. Participants in the interim analysis were heavily pre-treated, with over half having received more than five prior anti-cancer therapies, and a majority presenting with bone metastases.
Efficacy data were also encouraging, with all six participants with at least two post-treatment PSA results showing a decline in PSA levels. Four participants achieved PSA reductions greater than 50%, while two recorded reductions exceeding 80%. One participant achieved undetectable PSA levels with no cancer detected on imaging and reported a strong quality of life post-treatment.
The trial will continue enrolling patients through 2026, while planning for a Phase III registrational trial is ongoing. This update is considered price sensitive given the validation of safety and early efficacy signals without protocol changes.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au
x
Daily Dose of Buy, Sell & Hold recommendations before the market opens.
Start Your 7 Days Free Trial Now!
We use cookies to help us improve, promote, and protect our services. By continuing to use this site, we assume you consent to this. Read our Privacy Policy and Terms & Conditions
SECuRE Trial Continues Unchanged After Positive Safety Review
Clarity Pharmaceuticals (ASX: CU6) confirmed that the SECuRE trial will continue without any modifications following an interim review by the independent Safety Review Committee. The assessment covered evaluable data from nine participants enrolled in the Cohort Expansion Phase (Phase II) as of 25 November 2025.
The review showed a favourable safety profile for 67Cu-SAR-bisPSMA, with most treatment-related adverse events reported as Grade 1 or 2. Nausea and lymphopenia were the most common adverse events observed. Participants in the interim analysis were heavily pre-treated, with over half having received more than five prior anti-cancer therapies, and a majority presenting with bone metastases.
Efficacy data were also encouraging, with all six participants with at least two post-treatment PSA results showing a decline in PSA levels. Four participants achieved PSA reductions greater than 50%, while two recorded reductions exceeding 80%. One participant achieved undetectable PSA levels with no cancer detected on imaging and reported a strong quality of life post-treatment.
The trial will continue enrolling patients through 2026, while planning for a Phase III registrational trial is ongoing. This update is considered price sensitive given the validation of safety and early efficacy signals without protocol changes.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au