Tests ORIC-944 alone or with hormone drugs in metastatic prostate cancer
Tests the new drug ORIC-944 in adults with prostate cancer that has spread.
Plain-language title generated from the registry record
Registry title: Study of ORIC-944 in Patients With Metastatic Prostate Cancer
Key facts
- Where
- Bendigo, Frankston, and Wahroonga, AustraliaSee the 3 sites
- Phase
- Phase 1
Where in Australia
- Bendigo HealthBendigo, AustraliaTaking people
- Peninsula HealthFrankston, AustraliaNot yet recruiting
- Sydney Adventist HealthWahroonga, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ORIC Pharmaceuticals
- Trial code
- NCT05413421EU 2024-515527-11-00
- Record updated
- 9 July 2026
- Original 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.Read full original descriptionShow less
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
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.
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.