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Clinical Trial Summary

The study medication (BAY 2315497 Injection) is a thorium-227 labeled immuno-conjugate, specific for the prostate-specific membrane antigen (PSMA), which will be evaluated in patients with metastatic castration resistant prostate cancer. In this study, this investigational medication will be administered to patients for the first time. The primary objective of the study is to define the safety and tolerability profile and Maximal Tolerated Dose (MTD) of BAY2315497 Injection alone, or in combination with darolutamide. The secondary objectives are to determine the recommended dose for further clinical development of BAY2315497 Injection alone, or in combination with darolutamide and to investigate how the study drug is distributed and cleared from the body.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03724747
Study type Interventional
Source Bayer
Contact
Status Active, not recruiting
Phase Phase 1
Start date December 18, 2018
Completion date November 22, 2024

See also
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Completed NCT04516161 - EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)
Withdrawn NCT02130947 - Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide N/A