NCT03724747

Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 1, Open-label, First-in-human, Multi-center, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate, BAY 2315497 Injection Alone, and in Combination With Darolutamide (BAY 1841788), in Patients With Metastatic Castration Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	BAY2315497 Injection	BAY 2315497 Injection comprises 3 components: the PSMA-specific monoclonal antibody (mAb), the mAb-chelator conjugate, and the thorium-227 labeled mAb-chelator conjugate. BAY 2315497 Injection will be administered on Day 1 of each treatment cycle.
DRUG	Darolutamide(BAY1841788)	600 mg (2 X 300 mg tablets), twice daily with food, equivalent to a total daily dose of 1200 mg.

Timeline

• Start date: 2018-12-18
• Primary completion: 2022-08-25
• Completion: 2024-10-31
• First posted: 2018-10-30
• Last updated: 2024-11-08

Locations

5 sites across 3 countries: United States, Finland, United Kingdom

Regulatory

• FDA-regulated drug study