Study of ORIC-944 in Patients With Metastatic Prostate Cancer
NCT ID: NCT05413421
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
250 participants
INTERVENTIONAL
2022-06-01
2026-09-30
Brief Summary
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Detailed Description
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This is a first-in-human, open-label, multicenter, dose escalation study of ORIC-944 as a single agent (Part I) or in combination with an Androgen Receptor Pathway Inhibitor (ARPI) (Part II) to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combination with ARPIs in patients with metastatic prostate cancer. Part III of the protocol (dose optimization) will explore two potential dose levels of ORIC-944 selected from Part II in combination with ARPIs to select the final RP2D for each combination across two separate patient populations.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Single Agent Dose Escalation
ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles
ORIC-944
Oral, once daily, continuous
Combination Dose Escalation
ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combinations with abiraterone, apalutamide, darolutamide, or enzalutamide
ORIC-944
Oral, once daily, continuous
Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets
Oral, 1000 mg once daily, continuous
Apalutamide (Erleada™) 60 mg or 240 mg tablets
Oral, 240 mg once daily, continuous
Darolutamide (Nubeqa®) 300 mg tablets
Oral, 600 mg twice daily, continuous
Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Oral, 160 mg once daily, continuous
Combination Dose Optimization
Cohort A and C: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with apalutamide
Cohort B and D: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with darolutamide
Combinations with abiraterone or enzalutamide may be conducted in the future
ORIC-944
Oral, once daily, continuous
Apalutamide (Erleada™) 60 mg or 240 mg tablets
Oral, 240 mg once daily, continuous
Darolutamide (Nubeqa®) 300 mg tablets
Oral, 600 mg twice daily, continuous
Interventions
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ORIC-944
Oral, once daily, continuous
Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets
Oral, 1000 mg once daily, continuous
Apalutamide (Erleada™) 60 mg or 240 mg tablets
Oral, 240 mg once daily, continuous
Darolutamide (Nubeqa®) 300 mg tablets
Oral, 600 mg twice daily, continuous
Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Oral, 160 mg once daily, continuous
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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ORIC Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Pratik S. Multani, MD
Role: STUDY_DIRECTOR
ORIC Pharmaceuticals
Locations
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Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States
South Florida Oncology and Hematology
Plantation, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, United States
First Urology
Jeffersonville, Indiana, United States
Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland
Baltimore, Maryland, United States
Maryland Oncology Hematology
Silver Spring, Maryland, United States
Karmanos
Detroit, Michigan, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Memorial Sloane Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Amarillo Urology Research
Amarillo, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Virginia Oncology Associates
Fairfax, Virginia, United States
Virginia Cancer Specialists
Norfolk, Virginia, United States
University of Washington, Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Sydney Adventist Health
Wahroonga, New South Wales, Australia
Bendigo Health
Bendigo, Victoria, Australia
Peninsula Health
Frankston, Victoria, Australia
NEXT Oncology
Barcelona, Barcelona, Spain
Vall d'Hebron Institute of Oncology
Barcelona, Barcelona, Spain
NEXT Oncology
Madrid, , Spain
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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ORIC-944-01
Identifier Type: -
Identifier Source: org_study_id
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