Phase 1 Study of ORIC-944 Alone or With Androgen Receptor Pathway Inhibitors for Treatment of Metastatic Prostate Cancer

What this Trial Is About

Researchers are evaluating ORIC-944, a selective small molecule inhibitor targeting PRC2, in patients with metastatic prostate cancer. This open-label, phase 11b study aims to establish the safety and preliminary antitumor activity of ORIC-944 both alone and combined with androgen receptor pathway inhibitors ARPIs. The study involves patients who have progressed after prior ARPI therapies and explores dose escalation and optimization across different patient groups. Participants receive ORIC-944 orally once daily in 28-day continuous cycles either alone or combined with ARPIs such as abiraterone, apalutamide, darolutamide, or enzalutamide. The study has three parts Part I tests ORIC-944 alone Part II tests combinations with ARPIs Part III optimizes dosing of ORIC-944 with ARPIs in separate cohorts. Future combinations with abiraterone or enzalutamide may also be explored. During the study, participants undergo assessments including skin and tumor biopsies and monitoring of organ function and performance status. Researchers measure drug concentrations in the blood, antitumor responses, progression-free survival, and PSA levels. Safety and activity are evaluated over months, with follow-up for up to 36 months. The trial is sponsored by ORIC Pharmaceuticals and runs from 2022 to 2028.

Study of ORIC-944 in Patients With Metastatic Prostate Cancer