RecruitingPhase 1NCT07570979

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

208 participants

Start Date

May 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Abiraterone, a drug called Androgen deprivation therapy (ADT), and others for people with metastatic castration-resistant prostate cancer (mcrpc). The study is currently recruiting participants at 2 locations. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINR731

Oral administration

DRUGEnzalutamide

Oral administration

DRUGAbiraterone

Oral administration

DRUGAndrogen deprivation therapy (ADT)

Background therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.


Locations(3)

Mary Crowley Cancer Research

Dallas, Texas, United States

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Hirakata, Osaka, Japan

View Full Details on ClinicalTrials.gov

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NCT07570979


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