Study of ORIC-944 in Patients With Metastatic Prostate Cancer
ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorORIC Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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
Cohorts A and B: received only one 1 prior line of abiraterone in any setting
Evidence of progressive disease by PCWG3 criteria for study entry
Disqualifiers
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
Trial design
Treatments tested in this trial
- ORIC-944
- Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets
- Apalutamide (Erleada™) 60 mg or 240 mg tablets
- Darolutamide (Nubeqa®) 300 mg tablets
- Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Treatment groups
250 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov