Enrollment has started for the phase 1/2 SECURE trial examining the novel PSMA theranostic 64/67Cu SAR-bisPSMA in patients with metastatic castration-resistant prostate cancer (mCRPC), according to Clarity Pharmaceuticals, the company developing the treatment.1
Clarity reported in a release that the first clinical site for the trial (NCT04868604) opened at the Urology Cancer Center and GU Research Network in Omaha, Nebraska.
The theranostic 64/67Cu SAR-bisPSMA combines the PSMA PET imaging product 64Cu-SAR-bisPSMA and the PSMA targeted therapy 67Cu-SAR-bisPSMA. In the open-label, single-arm, dose-escalation SECURE trial, 64Cu-SAR-bisPSMA will be used for the selection of appropriate patients to receive treatment with 67Cu-SAR-bis-PSMA. The study aims to enroll 44 patients at multiple locations in the United States.
To enroll on the trial, patients must have mCRPC that has progressed despite being treated with androgen-deprivation therapy and at least 1 second-generation androgen receptor pathway inhibitor, such as abiraterone acetate (Zytiga) or enzalutamide (Xtandi).2 Patients are required to have an ECOG performance status of 0 to 2, and a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Individuals with brain metastases are not eligible to enroll.
The estimated study completion date for the SECURE trial is September 2026.
Clarity previously launched the phase 1 PROPELLER trial (NCT04839367), which is focused specifically on the imaging product 64Cu-SAR-bisPSMA in treatment-naïve patients with prostate cancer.3 The open-label, nonrandomized trial has a targeted enrollment of 30 patients. The estimated primary completion date is March 2022.
"We look forward to progressing both the SECURE and PROPELLER trials in patients with prostate cancer to build on the compelling results from our therapeutic and diagnostic preclinical studies. There is a high unmet need for early detection and better treatment options for patients with prostate cancer, especially with mCRPC, for which the median life expectancy is less than 3 years…We look forward to progressing these trials and getting closer to achieving our ultimate goal of developing better treatments for children and adults with cancer," Dr Alan Taylor, executive chairman of Clarity, stated in a press release.
PSMA-PET imaging has emerged as a new frontier in prostate cancer diagnosis and treatment. In December 2020, the FDA approved Gallium 68 PSMA-11 as the first product for PET imaging of PSMA-positive lesions in men with prostate cancer. Other PSMA products, such as the PSMA-targeted radiopharmaceutical 177Lu-PSMA-617, are now rapidly moving through the pipeline in prostate cancer.
1. Clarity commences Cu-64/Cu-67 SAR-bisPSMA theranostic prostate cancer trial Published online July 28, 2021. Accessed July 28, 2021. https://prn.to/3l1MSeZ.
2. NIH ClinicalTrials.gov. 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECURE). Last updated June 11, 2021. Accessed July 28, 2021. https://clinicaltrials.gov/ct2/show/NCT04868604.
3. Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER) . Last updated July 21, 2021. Accessed July 28, 2021. https://clinicaltrials.gov/ct2/show/NCT04839367