Clinical Trials | A First-in-human, Phase 1 Dose Escalation and Expansion Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of [225Ac]Ac-FL-020, an Anti-PSMA Radioconjugate (RDC), in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with a Metastatic Castration Resistant Prostate Cancer (mCRPC) for a research study. The purpose of the study is to learn about the effects of the investigational medicinal product, called [225Ac]Ac-FL-020, to see how safe [225Ac]Ac-FL-020 is for patients with mCRPC and to find the optimal dose for treating the disease. The study treatment belongs to a class of agents called “radiopharmaceuticals”. Additional information found here: https://clinicaltrials.gov/study/ NCT06492122 For questions, contact: [email protected] This study is divided into two parts: Part 1 will establish the optimal dose and safety profile of the study treatment for treatment of your disease without any high risks for your health. Part 2 will test this optimal dose in an extended number of patients to confirm the safety and check the preliminary anti-tumor activity of this optimal dose. The research study will include hospital visits, physical examinations, electrical tracing of the heart (called ECG), echocardiograms, body scans, vital signs measurements and taking blood and urine samples. You will receive treatment in this study for approximately 9 months, with an approximate number of 26 visits to the study site. The exact duration and the number of visits will depend on how long you will benefit from the treatment. After the treatment phase, there will be on-site follow-up visits every 3 months during the first 2 years and every 6 months in the subsequent years. In case you have discontinued treatment earlier because your cancer has worsened or because you have encountered some major safety events, you will only have phone calls every 3 months to assess your health status. The follow-up period is anticipated to last up to 5 years.