Title
An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination with an Androgen Receptor Pathway Inhibitor in Patients with Metastatic Prostate Cancer

Description
The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.

Objective
Primary:
- Part III: To select the optimal dose of ORIC-944 in combination with an ARPI
- Parts I, II, & III: To assess the pharmacokinetics (PK) of ORIC-944
- Food Effect Sub-Studies:
To evaluate the effect of food on the PK of ORIC-944 administered as a single agent or in combination with darolutamide

Secondary:
Parts II & III: To evaluate the preliminary antitumor activity of ORIC-944 in combination with an ARPI
Parts II & III: To evaluate additional indicators of antitumor activity of ORIC-944 in combination with an ARPI
Combination Food Effect Sub-Study: To evaluate the safety of ORIC-944 plus darolutamide combination when administered with food

Treatment This is a first-in-human, open-label, multicenter, dose escalation study of ORIC-944 as a single agent (Part I) or in combination with an Androgen Receptor Pathway Inhibitor (ARPI) (Part II) to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combination with ARPIs in patients with metastatic prostate cancer. Part III of the protocol (dose optimization) will explore two potential dose levels of ORIC-944 selected from Part II in combination with ARPIs to select the final RP2D for each combination across two separate patient populations.

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital