Clarity Pharmaceuticals is set to commence a pivotal Phase III trial, named AMPLIFY, for its 64Cu-SAR-bisPSMA diagnostic in patients with biochemical recurrence (BCR) of prostate cancer, following positive guidance from the U.S. FDA. The trial aims to evaluate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer, with patient recruitment expected to begin in early 2025.
The AMPLIFY trial is a non-randomized, single-arm, open-label, multi-center study that will enroll approximately 220 participants with rising or detectable PSA after initial definitive treatment. The study will evaluate imaging at two time points: the day of administration and approximately 24 hours post-administration.
Supporting Data from Prior Trials
The initiation of the AMPLIFY trial is backed by compelling data from the Phase I/II COBRA trial in patients with BCR of prostate cancer and the Phase I PROPELLER trial in patients with confirmed prostate cancer pre-prostatectomy/pre-definitive treatment. These trials demonstrated that 64Cu-SAR-bisPSMA is safe and exhibits significantly higher uptake in PSMA-expressing cancer lesions compared to standard-of-care (SOC) PSMA imaging agents.
Data from the COBRA trial indicated that 64Cu-SAR-bisPSMA could detect lesions smaller than 2 mm, outperforming SOC PSMA imaging agents. Furthermore, it identified lesions months before they were detectable by approved SOC PSMA agents. In the COBRA trial, 64Cu-SAR-bisPSMA identified lesions in approximately 60% of patients on same-day imaging and up to 80% on next-day imaging in whom standard of care imaging was unable to detect any lesions.
Executive Perspective
"We are very excited to progress our second Phase III trial with Clarity's lead product and appreciate the valuable guidance the FDA has provided in relation to our 64Cu-SAR-bisPSMA program to date," said Dr. Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals. "The data we have seen so far for this product has been incredibly favorable and we believe 64Cu-SAR-bisPSMA to be best-in-class."
Dr. Taylor also noted the potential benefits of 64Cu-SAR-bisPSMA's longer shelf-life (up to 48 hours) in improving patient access and broadening the use of radiopharmaceuticals to more clinical sites, overcoming the limitations of shorter half-life PSMA PET tracers like 18F- and 68Ga-based products.
About SAR-bisPSMA
SAR-bisPSMA utilizes Clarity's sarcophagine (SAR) technology, securely holding copper isotopes within a cage-like structure to prevent leakage. It can be used with copper-64 (64Cu) for imaging and copper-67 (67Cu) for therapy.
Prostate Cancer Statistics
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide. The American Cancer Institute estimates approximately 299,310 new cases in the US in 2024, with around 35,250 deaths.
