Registrational Phase III CLARIFY Trial in Prostate Cancer Commences

Reno, Nevada ( -- Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the Company”), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce it has commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)1, with the initiation of the first clinical site at the Urology Cancer Center / XCancer Omaha, NE.

The aim of the CLARIFY study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA to detect regional nodal metastasis in participants with high-risk prostate cancer prior to radical prostatectomy. The study expects to recruit 383 participants at multiple clinical sites across the United States and Australia.

Evaluation will take place over 2 imaging timepoints, day 1 (day of administration) and day 2 (approximately 24 hours post administration). CLARIFY is expected to image the first participant in late 2023. As a registrational trial, the final study results are intended to provide sufficient evidence to support an application to the US FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer.

Clarity’s Executive Chairman, Dr. Alan Taylor, commented, “We are excited to commence our first registrational Phase III trial with our optimised SAR-bisPSMA agent. The CLARIFY trial is based on compelling preclinical and clinical data, including our completed PROPELLER trial (NCT04839367)2,3. It demonstrated the excellent safety profile and superior performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 also in patients with prostate cancer prior to radical prostatectomy, guiding the study design for the CLARIFY trial. Despite the improvement of management and staging of patients with prostate cancer introduced by PSMA PET compared to other conventional imaging, low cancerous lesion uptake by PSMA agents may have an impact on clinical management. The PROPELLER trial showed significantly higher uptake of 64Cu-SAR-bisPSMA in PSMA-expressing lesions compared to an approved standard-of-care PSMA imaging agent, potentially enabling the diagnosis of additional and smaller lesions2,3. CLARIFY will also investigate the benefits of delayed imaging in this patient group, a feature that has shown real benefits to patients so far and is not available with the first-generation PSMA imaging agents using gallium-68 or fluorine-18, which have very short half-lives and exhibit low sensitivity in detecting cancerous lesions. Additionally, the extended shelf-life of up to 48 hours offered by 64Cu-SAR-bisPSMA not only provides greater flexibility for clinics in scheduling diagnostic scans, but also improves patient access to care, including areas with limited access to diagnostic radiopharmaceuticals in prostate cancer due to the short shelf-life of existing PSMA PET tracers.

“The prostate cancer market is a key focus area for Clarity as there is a high unmet need for diagnostics and therapy, and we believe our theranostic SAR-bisPSMA product has the potential to improve diagnosis, therapy and ultimately change patients’ lives. We look forward to progressing this trial to validate and expand upon the positive data we have accumulated so far with our SAR-bisPSMA product. With this trial, our aspiration is that with improved diagnostic tools, clinicians will be empowered to make more informed decisions regarding the best course of treatment for their patients.”
Source: Clarity Pharmaceuticals. (2023). Registrational Phase III CLARIFY Trial in Prostate Cancer Commences [Press release].