A Phase 2 Open-label Study Evaluating Dosimetry Randomized Dose Optimization Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA PET-Positive Castration-Resistant Prostate Cancer

Brief description of study

This is a three-part study which includes biodistribution (Part 1), dose optimization (Part 2) to determine the optimal dose of Ac-225 rosopatamab tetraxetan to be evaluated in future studies, and dose escalation (Part 3) in post-Lu-177-PSMA-RL participants using the Bayesian optimal interval (BOIN) design. The study will evaluate participants with CRPC previously treated with at least one ARSI with and without prior exposure to Lu-177-PSMA-RL.


Clinical Study Identifier: s24-00058
ClinicalTrials.gov Identifier: NCT06549465
Principal Investigator: David R. Wise.
Other Investigators: Tori A Yuen, Doris Leithner, Minas Platon Economides, Victor Ricardo Adorno Febles, Scot Niglio, Kent P Friedman, Mona P. Natwa.


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