Actively Recruiting
Study of ORIC-944 in Patients With Metastatic Prostate Cancer
Led by ORIC Pharmaceuticals · Updated on 2025-08-11
250
Participants Needed
27
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of ORIC-944 in Patients With Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- For Part I: Any number of prior therapies allowed but must have progressed after at least one line of next generation ARPI and received no more than 2 chemotherapy regimens in mCRPC setting
- For Part II: Must have received only 1 prior line of ARPI in any setting; may have received up to 1 prior chemotherapy line in mCSPC setting
- For Part III: In addition to up to 1 prior chemotherapy line in mCSPC setting, cohorts A and B must have received 1 prior line of abiraterone; cohorts C and D must have received 1 prior line of apalutamide, darolutamide, or enzalutamide
- Evidence of progressive disease by PCWG3 criteria (rising PSA, new bone lesions, or soft tissue progression)
- Measurable and/or evaluable disease by RECIST 1.1
- Agreement and ability to undergo skin and tumor biopsies
- ECOG performance status 0 or 1
- Adequate organ function
You will not qualify if you...
- 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 6 months
- Known, symptomatic HIV infection
- Active symptomatic Hepatitis B or C infection (well controlled disease allowed)
- Active gastrointestinal disease or malabsorption syndromes impacting drug absorption
- Any condition interfering with protocol compliance or contraindicating participation as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 27 locations
1
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
2
South Florida Oncology and Hematology
Plantation, Florida, United States, 33322
Actively Recruiting
3
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Actively Recruiting
4
Comprehensive Urologic Care
Lake Barrington, Illinois, United States, 60010
Actively Recruiting
5
First Urology
Jeffersonville, Indiana, United States, 47130
Actively Recruiting
6
Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
7
Maryland Oncology Hematology
Silver Spring, Maryland, United States, 20904
Actively Recruiting
8
Karmanos
Detroit, Michigan, United States, 48201
Actively Recruiting
9
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
10
Memorial Sloane Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
11
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
12
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Not Yet Recruiting
13
Keystone Urology Specialists
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
14
Amarillo Urology Research
Amarillo, Texas, United States, 74035
Actively Recruiting
15
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Actively Recruiting
16
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
17
Virginia Oncology Associates
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
Virginia Cancer Specialists
Norfolk, Virginia, United States, 23502
Not Yet Recruiting
19
University of Washington, Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
20
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
21
Sydney Adventist Health
Wahroonga, New South Wales, Australia
Actively Recruiting
22
Bendigo Health
Bendigo, Victoria, Australia
Actively Recruiting
23
Peninsula Health
Frankston, Victoria, Australia
Not Yet Recruiting
24
NEXT Oncology
Barcelona, Barcelona, Spain
Actively Recruiting
25
Vall d'Hebron Institute of Oncology
Barcelona, Barcelona, Spain
Actively Recruiting
26
NEXT Oncology
Madrid, Spain
Actively Recruiting
27
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Actively Recruiting
Research Team
O
ORIC Clinical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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