MedTrace Logo

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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-26
Primary Completion
2030-06-03
Completion
2030-06-03
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570979 on ClinicalTrials.gov