drugset / Trial / NCT07570979

A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer

NCT07570979

Phase 1 Recruiting 208 enrolled Novartis Pharmaceuticals
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastatic prostate cancer.

Timeline

Start
2026-05-25
Primary completion
2030-06-03
Completion
2030-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule Oral
Subject Enzalutamide Other / unclassified Oral
Subject INR731 Unknown Oral