A phase 2 trial of investigational PET imaging agent 64Cu SAR-Bombesin is underway for PSMA-PET negative patients with biochemically recurrent prostate cancer.
The SABRE trial is being conducted by 64Cu SAR-Bombesin’s developer Clarity Pharmaceuticals. In a press release, the organization said that the trials began to address the unmet need faced by the 20% of patients who have biochemically recurrent prostate cancer and who are PSMA-PET negative. These patients are not able to respond to newer PSMA-targeted treatments and are typically left with few treatment options.
64Cu SAR-Bombesin targets the Gastrin Releasing Peptide receptor (GRPr) which is found in prostate tumors. The SABRE trial will enroll up to 50 patients with known or suspected PSMA-negative biochemically recurrent prostate cancer after definitive therapy such as surgery or radiation. The safety and tolerability of 64Cu SAR-Bombesin are the primary outcome measures of the study, along with its ability to accurately detect prostate cancer recurrence.
A pilot trial of the agent demonstrated safety and efficacy among breast cancer patients, and results were presented at the 2022 ASCO Annual Meeting.
“We are very excited to initiate patient accrual for the SABRE trial which will explore and validate the clinical benefits associated with the novel SAR-Bombesin agent…we believe it is an agent with high diagnostic and therapeutic potential. We hope this trial will inform us on the role of SAR-Bombesin in diagnosing disease in PSMA-negative prostate cancer patients by imaging patients on day of injection and at ~24 hours after injection, with the delayed imaging being a novel feature enabled by 64Cu,” Andrei Iagaru, MD, lead principal investigator on the SABRE trial, stated in a press release.
Dr. Lagaru added that: “In addition to investigating the clinical benefits of the product, we also look forward to leveraging centralized manufacture and on-demand delivery advantages of copper-based products. These features have potential to facilitate universal access to SAR-Bombesin and enhance accessibility to treatment facilities throughout the United States.”