Radiopharm Theranostics Ltd. announced it has dosed the first patient in its first-in-human Phase 1/2a clinical trial of 177Lu-BetaBart (RV-01). The dose escalation and expansion study is designed to evaluate safety, biodistribution and radiation dosimetry, as well as preliminary anti-tumor activity, and to determine a recommended dose for future studies. The company also referenced preclinical animal studies reporting tumor shrinkage and prolonged survival, and noted that the FDA provided IND clearance for Betabart (RV-01) on 28 July 2025.
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