NCT05413421

Study of ORIC-944 in Patients With Metastatic Prostate Cancer

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: ORIC Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

ORIC-944 is a potent, highly selective, allosteric, orally bioavailable, small molecule inhibitor of PRC2 via binding the embryonic ectoderm development (EED) subunit. 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.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	ORIC-944	Oral, once daily, continuous
DRUG	Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets	Oral, 1000 mg once daily, continuous
DRUG	Apalutamide (Erleada™) 60 mg or 240 mg tablets	Oral, 240 mg once daily, continuous
DRUG	Darolutamide (Nubeqa®) 300 mg tablets	Oral, 600 mg twice daily, continuous
DRUG	Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets	Oral, 160 mg once daily, continuous

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-12-01
• Completion: 2026-09-01
• First posted: 2022-06-10
• Last updated: 2025-08-11

Locations

27 sites across 4 countries: United States, Australia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study