Testing ORIC-944 for metastatic prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and preliminary effectiveness of ORIC-944, a selective small molecule inhibitor targeting PRC2, in patients with metastatic prostate cancer. The study is divided into three parts: the first part assesses ORIC-944 as a standalone treatment, the second part examines its use in combination with various Androgen Receptor Pathway Inhibitors (ARPIs), and the third part focuses on optimizing the dosage of ORIC-944 in combination with ARPIs. The trial is designed to identify the maximum tolerated dose and gather initial data on its antitumor activity.

Why it matters

Who can join: the full rules

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 prior line of ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in any setting; may have also received up to 1 prior line of chemotherapy in the mCSPC setting

Part III (ARPI combination dose optimization): In addition to up to 1 prior line of chemotherapy in the mCSPC setting:

* 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

Exclusion Criteria:

* 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

Where it's running

• Rocky Mountain Cancer Center
  Colorado Springs, Colorado, United States Recruiting
• South Florida Oncology and Hematology
  Plantation, Florida, United States Recruiting
• Illinois Cancer Specialists
  Arlington Heights, Illinois, United States Recruiting
• Comprehensive Urologic Care
  Lake Barrington, Illinois, United States Recruiting
• First Urology
  Jeffersonville, Indiana, United States Recruiting
• Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: ORIC Clinical
• Email: clinical@oricpharma.com
• Phone: 650-388-5600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.