RecruitingPhase 1NCT05413421

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

Sponsor

ORIC Pharmaceuticals

Enrollment

250 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ORIC-944 — alone and in combination with other hormone-blocking treatments — for men with metastatic prostate cancer that is no longer responding to standard hormone therapy (castration-resistant prostate cancer). **You may be eligible if...** - You have metastatic prostate cancer that has stopped responding to hormone therapy - You have undergone surgical removal of the testes or are on hormone-suppressing injections - For the single-agent phase: you have tried at least one next-generation hormone blocker (abiraterone, apalutamide, darolutamide, or enzalutamide) and it stopped working - For the combination phase: you have received only one prior hormone blocker **You may NOT be eligible if...** - You have not yet tried any hormone-blocking therapies - You have received more than 2 chemotherapy regimens for advanced prostate cancer - You have other serious health conditions that make the treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Colorado Springs, Colorado, United States

South Florida Oncology and Hematology

Plantation, Florida, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Comprehensive Urologic Care

Lake Barrington, Illinois, United States

First Urology

Jeffersonville, Indiana, United States

Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland

Baltimore, Maryland, United States

Maryland Oncology Hematology

Silver Spring, Maryland, United States

Karmanos

Detroit, Michigan, United States

Minnesota Oncology Hematology

Minneapolis, Minnesota, United States

Memorial Sloane Kettering Cancer Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

Amarillo Urology Research

Amarillo, Texas, United States

Urology Clinics of North Texas

Dallas, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Virginia Oncology Associates

Fairfax, Virginia, United States

Virginia Cancer Specialists

Norfolk, Virginia, United States

University of Washington, Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Sydney Adventist Health

Wahroonga, New South Wales, Australia

Bendigo Health

Bendigo, Victoria, Australia

Peninsula Health

Frankston, Victoria, Australia

NEXT Oncology

Barcelona, Barcelona, Spain

Vall d'Hebron Institute of Oncology

Barcelona, Barcelona, Spain

NEXT Oncology

Madrid, Spain

Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05413421

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