Phase 2 of SOLAR, a clinical trial designed by Curium Pharma, achieved its co-primary end points of region-level correct localization rate and patient-level correct detection rate for the use of Copper Cu 64 prostate-specific membrane antigen (PSMA) I&T injections in patients with histologically proven metastatic prostate cancer.
The SOLAR trial aimed to evaluate the safety, biodistribution, and image quality of Copper Cu 64 PSMA I&T to detect metastatic prostate cancer using positron emission tomography/computed tomography (PET/CT) imaging. A total of 26 patients with metastatic prostate cancer were administered Copper Cu 64 PSMA I&T injections in 7- to 9-mCi intravenous doses. PET/CT images were taken for each patient at 1 hour ± 15 minutes and 4 hours ± 30 minutes after administration.
“We are very pleased to report that our Copper Cu 64 PSMA I&T product for PET/CT imaging in the detection of recurrent prostate cancer has met the co-primary end points,” said Sakir Mutevelic, MD, MSc, chief medical officer at Curium, in a press release. “Consistent with our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are encouraged by the readouts of the SOLAR phase 2 clinical trial. Our goal is to accelerate the Copper Cu 64 PSMA I&T phase 3 clinical development and move forward with pivotal phase 3 clinical trials in biochemical recurrence and initial staging setting in metastatic prostate cancer in early 2024.”