The FDA has cleared an Investigational New Drug (IND) application for ART-101, a new radiopharmaceutical agent intended for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This clearance allows the launch of a phase 1 clinical trial in patients with PSMA-positive mCRPC, expected to begin later this year.

ART-101 is a small molecule that targets prostate-specific membrane antigen (PSMA), a protein commonly expressed in advanced prostate cancer. Designed as a theranostic agent, ART-101 combines the ability to image and treat tumors using radioactive isotopes, with the goal of improving precision while reducing harm to healthy tissues.

In preclinical studies, ART-101 showed higher tumor uptake and retention than currently approved PSMA-targeting agents, along with reduced uptake in normal tissues such as salivary glands. These findings suggest the potential for enhanced treatment effectiveness and fewer side effects. The agent is also compatible with several therapeutic isotopes, including actinium-225, lutetium-177, and terbium-161. Data from preclinical testing indicate that ART-101, particularly when paired with alpha-emitting isotopes, may offer a more effective and safer alternative to existing radiopharmaceutical treatments.

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