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New treatment option for Metastatic Prostate Cancer
Official title Study of ORIC-944 in Patients With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT05413421
What this study is testing
What is ORIC-944?
ORIC-944 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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:
You likely can't join if
- 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...
- 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...
- Any other condition or circumstance (eg, clinical, psychological, familial, sociological, inability to swallow oral study drug) that, in the opinion...
See the full 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: 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Colorado Springs, Colorado, United States
- Plantation, Florida, United States
- Arlington Heights, Illinois, United States
- Lake Barrington, Illinois, United States
- Jeffersonville, Indiana, United States
- Baltimore, Maryland, United States
- Silver Spring, Maryland, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Bala-Cynwyd, Pennsylvania, United States
- Lancaster, Pennsylvania, United States
- Amarillo, Texas, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
- Norfolk, Virginia, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colorado Springs, Colorado, United States; Plantation, Florida, United States; Arlington Heights, Illinois, United States; Lake Barrington, Illinois, United States; Jeffersonville, Indiana, United States; Baltimore, Maryland, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.