Phase 1 Trial Will Soon Start Recruiting: ACE-232 a Promising Inhibitor of CYP11A1
A new prostate cancer treatment is advancing, a novel CYP11A1 inhibitor, ACE-232. This orally active and highly selective inhibitor targets both localized and metastatic hormone-sensitive or castration-resistant prostate cancer. Notably, ACE-232 has demonstrated the ability to overcome resistance to androgen receptor pathway inhibitors (ARPIs) caused by AR-LBD mutations or amplification.
Preclinical studies have showcased ACE-232’s excellent in vitro and in vivo potency, along with a favorable pharmacokinetic and safety profile. These promising results have led to the FDA’s approval for a Phase I clinical trial. This open-label, multi-center study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ACE-232 in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial is structured in two parts: Phase 1A focuses on dose escalation to determine the maximum tolerated dose and establish a recommended Phase 2 dose range, while Phase 1B involves dose optimization based on the findings from Phase 1A. Recruitment should start in April 2025.