Arteus Technologies announced that the first patient has been dosed in a phase 1 trial of ART-101 for metastatic castration-resistant prostate cancer (mCRPC).
ART-101 is a novel, receptor-based small molecule designed for both imaging and treatment of prostate cancer. Preclinical studies suggest it offers higher tumor uptake and retention while minimizing absorption in normal tissues and salivary glands, compared with existing PSMA-targeting radioligand therapies.
“Current radioligand therapies provide meaningful benefits for advanced prostate cancer, but there is potential to further improve patient quality of life and reduce side effects,” said Dr. Harshad Kulkarni, chief medical advisor at BAMF Health and principal investigator of the trial. He noted that lower salivary gland uptake could help mitigate xerostomia, an important consideration for upcoming alpha emitter-based therapies.
ART-101 was discovered at the Advanced Radiotheranostics Lab at the University of Wisconsin, Madison, under Reinier Hernandez, PhD, MS, who serves as chief technology officer at Arteus Technologies and assistant professor of medical physics at the University of Wisconsin School of Medicine and Public Health.
The phase 1 study will evaluate ART-101’s safety, feasibility, biodistribution, kinetics, and tumor targeting using SPECT/CT imaging with [111In]In-ART-101. Approximately 10 patients with mCRPC who are eligible for [177Lu]Lu-PSMA-617 (Pluvicto) therapy are expected to enroll. Patients receiving concurrent chemotherapy, immunotherapy, radiopharmaceutical therapy, or other investigational treatments are excluded.
Each participant will undergo eight SPECT/CT scans—four after [111In]In-ART-101 administration and four after [177Lu]Lu-PSMA-617 administration—and will be followed for roughly two months.
“With promising preclinical results and strong development support, ART-101 represents an innovative approach that could overcome key limitations of current radiopharmaceutical therapies,” said Hernandez. “This trial underscores Arteus’ commitment to precision imaging, dosimetry, and advancing our broader therapeutic platform for prostate cancer.”
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