Phase I Study of Oral INR731 Alone or With Androgen Receptor Inhibitors for Adult Men With Metastatic Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes the drug, early anti-tumor effects, and appropriate dosing of INR731 alone and combined with standard androgen receptor pathway inhibitors ARPIs in adult men with metastatic prostate cancer. This first-in-human, open-label Phase I study includes patients with metastatic castration-resistant prostate cancer mCRPC who have progressed on or are not candidates for standard treatments. The study has three treatment groups INR731 alone Arm A, INR731 with enzalutamide Arm B, and INR731 with abiraterone Arm C. The single agent group includes dose escalation then possible dose expansion to assess safety and preliminary activity, including patients with post-standard care mCRPC and those with rapid castration resistance. The combination arms also start with dose escalation, followed by dose expansion of INR731 with enzalutamide in first-line mCRPC patients. Participants will receive oral INR731, either alone or combined with enzalutamide or abiraterone, alongside ongoing androgen deprivation therapy. Researchers will monitor side effects, dose adjustments, and drug levels up to about 24 months. They will evaluate anti-tumor responses, progression-free survival, and PSA response. Regular imaging and lab tests will assess disease status and drug pharmacokinetics throughout the study period.

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