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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
Sponsor: Novartis Pharmaceuticals
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.
Official title: An Open-label, Multi-center, First in Human Phase I Global Dose Escalation and Expansion Study of INR731 Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
208
Start Date
2026-05-26
Completion Date
2030-06-03
Last Updated
2026-05-06
Healthy Volunteers
No
Interventions
INR731
Oral administration
Enzalutamide
Oral administration
Abiraterone
Oral administration
Androgen deprivation therapy (ADT)
Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.
Locations (2)
Mary Crowley Cancer Research
Dallas, Texas, United States
Novartis Investigative Site
Melbourne, Victoria, Australia