Stopped: Recruitment for PROter A206T-G01-001 (NCT03490838) was halted in Phase I by sponsor decision. Phase II expansion portion of the study was never initiated.
This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine the recommended dose of 177Lu-PSMA-R2 for radio-ligand therapy (RLT) of mCRPC, and the Phase 2 portion will expand into approximately 60 patients documenting the preliminary activity (anti-tumor response) of repeated treatments administered, continuing safety assessments and collecting QoL data.
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Phase I: Incidence of dose limiting toxicities (DLTs) during first cycle of study treatment.
Timeframe: Up to 8 weeks after the first 177Lu-PSMA-R2 dose
Phase II: Prostate-Specific Antigen (PSA) response rate 50
Timeframe: Week 13 (12 weeks after the first 177Lu-PSMA-R2 injection)