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
ORIC Pharmaceuticals
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Patients with metastatic prostate cancer * Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone * Prior therapies: Part I (single agent ORIC-944 dose escalation): Any number of prior therapies are allowed, but must have progressed after at least one line of next generation ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC setting Part II (ARPI combination dose escalation): Must have received only 1…
Interventions
- DrugORIC-944
Oral, once daily, continuous
- DrugAbiraterone acetate (Zytiga®) 250 mg or 500 mg tablets
Oral, 1000 mg once daily, continuous
- DrugApalutamide (Erleada™) 60 mg or 240 mg tablets
Oral, 240 mg once daily, continuous
- DrugDarolutamide (Nubeqa®) 300 mg tablets
Oral, 600 mg twice daily, continuous
- DrugEnzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Oral, 160 mg once daily, continuous
Locations (27)
- Rocky Mountain Cancer CenterColorado Springs, Colorado
- South Florida Oncology and HematologyPlantation, Florida
- Illinois Cancer SpecialistsArlington Heights, Illinois
- Comprehensive Urologic CareLake Barrington, Illinois
- First UrologyJeffersonville, Indiana
- Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of MarylandBaltimore, Maryland