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RECRUITING
NCT07570979
PHASE1

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

View on ClinicalTrials.gov

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

DRUG

INR731

Oral administration

DRUG

Enzalutamide

Oral administration

DRUG

Abiraterone

Oral administration

DRUG

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