Skip to main content
Metastatic Castration-resistant Prostate Cancer (mCRPC)Prostate healthFirst-in-humanCancerMen's healthDrugPhase 1

What this study is

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.

What's being tested

  • INR731

    Intervention · DRUG

  • Enzalutamide

    Intervention · DRUG

  • Abiraterone

    Intervention · DRUG

  • Androgen deprivation therapy (ADT)

    Intervention · DRUG

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

All of INR731, Enzalutamide, Abiraterone

Oral administration

Study details

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
Sponsor
Novartis Pharmaceuticals
Conditions
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Enrolling
208 people
Starts
2026-05-25
Est. completion
2030-06-03
Design
Open-label, non-randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗