On October 6, 2026 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company, reported that the first patient has been successfully imaged in a Phase 2 clinical trial evaluating the diagnostic accuracy and safety of the Company’s 61Cu-NU101 radiotracer in patients with metastatic prostate cancer. 61Cu-NU101 is a positron emission tomography (PET) imaging agent that effectively combines high-radiopure Copper-61 with a targeting peptide to specifically bind to Prostate-Specific Membrane Antigen (PSMA), an established biomarker for prostate cancer. 61Cu-NU101 is the diagnostic component of NUCLIDIUM’s NU101 theranostic program for metastatic prostate cancer, paired with the 67Cu-NU101 therapeutic.
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"PSMA-targeted PET is currently the best method of imaging metastatic prostate cancer, and we are always striving to do better. In a phase 1 trial, we showed that 61Cu-NU101 was safe and able to detect additional lesions in 50% of patients compared to the currently most sensitive imaging agents", said Dr. Gary Ulaner, MD, PhD, Chair of Molecular Imaging and Therapy at the Hoag Family Cancer Institute and Professor of Radiology at the University of Southern California. "These data supported the opening of our phase 2 trial, which is statistically powered to compare against currently available imaging agents and uses pathology as the reference standard of truth."
The investigator-initiated, non-randomized Phase 2 trial will enroll approximately 34 patients with biopsy-confirmed metastatic prostate cancer at clinical sites in the United States. Patients will receive a single intravenous dose of 61Cu-NU101, followed by PET/CT imaging at 1 and 4 hours post-dose. The primary endpoint will evaluate the sensitivity of tumor lesion detection of 61Cu-NU101 compared to an 18F-based, FDA-approved PSMA-targeting radiotracer. Secondary endpoints include a sensitivity comparison to CT and bone scans, and safety evaluation.
"The supportive Phase 1 diagnostic data and differentiated clinical profile reinforce our belief in the best-in-class potential of NU101 as a next-generation copper-based radiotheranostic for prostate cancer. Importantly, progress in our diagnostic program will inform and strengthen our therapeutic development strategy, enabling our true radiotheranostic approach of direct diagnosis to treatment conversion. The initiation of this Phase 2 trial represents an important step in executing our broad and robust development plan, with multiple clinical trials expected over the coming months and expansion into new cancer patient populations," said Thomas Reiner, PhD, CSO of NUCLIDIUM.
NUCLIDIUM’s 61Cu-NU101 program can be manufactured in 5 minutes at room-temperature, allowing for on-demand preparation and seamless integration into existing hospital infrastructure. These manufacturing advantages, coupled with the longer half-life, delayed imaging capability and beneficial tumor-to-background ratio, further underscore the benefits of this copper-based approach compared with alternative radioligands. Phase 1 data previously presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting highlight the favorable clinical profile of 61Cu-NU101.
(Press release, NUCLIDIUM, OCT 6, 2026, View Source [SID1234673216])