Clarity’s AMPLIFY Trial Images Its First Patient

Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company focused on developing next-generation cancer treatments, has announced that it has successfully imaged the first patient in its registrational Phase III diagnostic trial, AMPLIFY. This trial evaluates the use of ⁶⁴Cu-SAR-bisPSMA in patients with biochemical recurrence (BCR) of prostate cancer. The imaging was conducted at XCancer in Omaha, Nebraska (NE).

The AMPLIFY trial is a non-randomized, single-arm, open-label, multi-center diagnostic clinical trial evaluating ⁶⁴Cu-SAR-bisPSMA PET imaging in men with biochemical recurrence (BCR) of prostate cancer, defined as rising or detectable prostate-specific antigen (PSA) levels following definitive treatment.

The trial aims to assess the effectiveness of ⁶⁴Cu-SAR-bisPSMA PET/CT in detecting recurrent prostate cancer. Imaging is conducted at two time points. AMPLIFY plans to enroll about 220 participants at clinical sites across the United States and Australia. Its findings will support a submission to the U.S. Food and Drug Administration (FDA) for the approval of ⁶⁴Cu-SAR-bisPSMA as a new diagnostic imaging agent for BCR in prostate cancer.

"We are thrilled to recruit the first participant in the AMPLIFY trial and to image them just over a week after study initiation. 64Cu-SAR-bisPSMA could become a best-in-class diagnostic prostate-specific membrane antigen (PSMA) agent, and we are honored to be part of this registrational trial that intends to gather sufficient data for a New Drug Application (NDA) and a potential subsequent commercialization of this next-generation product,” commented Dr. Luke Nordquist, Urologic Medical Oncologist, CEO, XCancer.

Additionally, Nordquist noted, "We have already observed the potential benefits of 64Cu-SAR-bisPSMA based on data from earlier phase trials such as Clarity's PROPELLER and COBRA studies and look forward to participating in the AMPLIFY trial, providing this optimized product to our patients in need of novel diagnostic solutions. The COBRA trial that laid the foundation for AMPLIFY in patients with BCR of prostate cancer showed that more lesions and more patients with a positive scan were identified on 64Cu-SAR-bisPSMA positron emission tomography (PET) compared to conventional scans and on next-day vs. same-day imaging.”

Clarity's Executive Chairperson, Dr Alan Taylor, commented, "We are excited to have imaged the first patient in the AMPLIFY trial and look forward to further progressing recruitment and opening clinical sites across the United States (US) and Australia, providing access to 64Cu-SAR-bisPSMA in both countries as part of this trial. With prostate cancer prevalence increasing year after year, we look forward to overcoming limitations of the current-generation PSMA PET diagnostics, such as sensitivity and accessibility, making earlier and more accurate detection of recurrent disease a potential reality and bringing our optimized diagnostic to more men with this insidious disease around the world."