drugset
drugset / Trial / NCT03490838

177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer

NCT03490838 ↗

Phase 1 Terminated 27 enrolled Advanced Accelerator Applications
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2018-05-24
Primary completion
2021-05-26
Completion
2022-06-02

Outcome

Outcome not reported

Stopped (Enrollment): “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.”

Drugs

EvaluationDrugModalityDoseRoute
Subject LUTETIUM PSMA-R2 Other / unclassified 3700 mbq —
Subject LUTETIUM PSMA-R2 Other / unclassified 7400 mbq —
Subject LUTETIUM PSMA-R2 Other / unclassified 11100 mbq —
Subject LUTETIUM PSMA-R2 Other / unclassified 14800 mbq —
Subject LUTETIUM PSMA-R2 Other / unclassified 18500 mbq —

Indications

prostate neoplasm