New clinical trial collaboration for treatment of prostate cancer

Clarity Pharmaceuticals announced that an investigator-initiated trial (IIT) will commence shortly in the US investigating 64Cu SAR-bisPSMA in prostate cancer (NCT05286840)[1}.

The X-Cancer’s investigator-led trial of SAR-bisPSMA in known or suspected prostate cancer (X-Calibur) is a Phase I/II IIT in up to 150 patients at the Urology Cancer Center and GU Research Network (GURN) in Omaha, Nebraska, sponsored by Dr Luke Nordquist. It will investigate a broad spectrum of prostate cancer patients by imaging with 64Cu-SAR-bisPSMA on the day of administration and at later timepoints. The X-Calibur trial will be assessing the safety of 64Cu SAR-bisPSMA as well as looking at the impact of the product on staging and clinical management of participants with prostate cancer.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, “We are excited to support Dr Nordquist’s  trial, who has had first-hand experience with our products in the theranostic 64Cu/67Cu SAR-bisPSMA SECuRE trial (NCT04868604)[2]. We look forward to continuing to work together on progressing the development of our optimised SAR-bisPSMA agent in prostate cancer and exploring the many benefits of this product as part of Clarity’s Targeted Copper Theranostics (TCT) program in pursuit of our ultimate goal of improving treatment outcomes for cancer patients.”

Prostate cancer is a key focus of Clarity’s Targeted Copper Theranostics (TCT) program, where the IIT at GURN is the fourth clinical trial utilising the SAR-bisPSMA agent in prostate cancer. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)[2], has been able to successfully image patients with metastatic castrate resistant prostate cancer from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)[3], is well underway, with over 50% of participants recruited in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy). The most recent diagnostic 64Cu SAR-bisPSMA trial in the US, COBRA (NCT05249127)[4], has received a Study May Proceed Letter from the FDA in February 2022, with recruitment of participants with biochemical recurrence of prostate cancer planned to commence in the second quarter of 2022. Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.