Study of ORIC-944 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.

Conditions

Metastatic Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

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

Study of ORIC-944 in Patients with Metastatic Prostate Cancer

Condition
Metastatic Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Plantation

South Florida Oncology and Hematology, Plantation, Florida, United States, 33322

Jeffersonville

First Urology, Jeffersonville, Indiana, United States, 47130

Baltimore

Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, Maryland, United States, 21201

Detroit

Karmanos, Detroit, Michigan, United States, 48201

New York

Memorial Sloane Kettering Cancer Center, New York, New York, United States, 10065

Charlotte

Levine Cancer Institute, Charlotte, North Carolina, United States, 28204

Lancaster

Keystone Urology Specialists, Lancaster, Pennsylvania, United States, 17601

Dallas

Urology Clinics of North Texas, Dallas, Texas, United States, 75231

Salt Lake City

Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States, 84112

Seattle

University of Washington, Fred Hutchinson Cancer Center, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * Cohorts A and B: received only one 1 prior line of abiraterone in any setting
  • * Cohorts C and D: received only one 1 prior line of apalutamide, darolutamide, or enzalutamide in any setting:
  • * Evidence of progressive disease by PCWG3 criteria for study entry
  • * rising PSA, defined as a minimum of 2 rising values obtained a minimum of one week apart with the latest result being at least 2.0 ng/mL (or 1.0 ng/mL if PSA rise is the only indication of progression), or
  • * confirmation of 2 new bone lesions on last systemic therapy, or
  • * soft tissue progression per RECIST 1.1
  • * Measurable and/or evaluable disease by RECIST 1.1
  • * Agreement and ability to undergo on-study punch skin biopsies and core tumor biopsies
  • * ECOG performance status of 0 or 1
  • * Adequate organ function
  • * History or presence of CNS metastases, unless previously treated and stable
  • * History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months
  • * Known, symptomatic human immunodeficiency virus (HIV) infection
  • * Active symptomatic Hepatitis B or C infection; patients with well controlled disease are eligible
  • * Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, short gut syndrome, etc) or other malabsorption syndromes that would reasonably impact drug absorption per investigator judgement
  • * Any other condition or circumstance (eg, clinical, psychological, familial, sociological, inability to swallow oral study drug) that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

ORIC Pharmaceuticals,

Pratik S. Multani, MD, STUDY_DIRECTOR, ORIC Pharmaceuticals

Study Record Dates

2026-09