Status:
RECRUITING
Study of ORIC-944 in Patients With Metastatic Prostate Cancer
Lead Sponsor:
ORIC Pharmaceuticals
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
ORIC-944 is a potent, highly selective, allosteric, orally bioavailable, small molecule inhibitor of PRC2 via binding the embryonic ectoderm development (EED) subunit. This is a first-in-human, open-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05413421
Start Date
June 1 2022
End Date
September 1 2026
Last Update
August 11 2025
Active Locations (27)
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1
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States, 80907
2
South Florida Oncology and Hematology
Plantation, Florida, United States, 33322
3
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
4
Comprehensive Urologic Care
Lake Barrington, Illinois, United States, 60010