Study of ORIC-944 in Patients With Metastatic Prostate Cancer

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
ORIC Pharmaceuticals
Study ID
NCT05413421
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ORIC-944 — DRUG
    Oral, once daily, continuous
  • Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets — DRUG
    Oral, 1000 mg once daily, continuous
  • Apalutamide (Erleada™) 60 mg or 240 mg tablets — DRUG
    Oral, 240 mg once daily, continuous
  • Darolutamide (Nubeqa®) 300 mg tablets — DRUG
    Oral, 600 mg twice daily, continuous
  • Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets — DRUG
    Oral, 160 mg once daily, continuous

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Agent Dose Escalation
    ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles
  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer CenterColorado SpringsColorado80907-
South Florida Oncology and HematologyPlantationFlorida33322-
Illinois Cancer SpecialistsArlington HeightsIllinois60005-
Comprehensive Urologic CareLake BarringtonIllinois60010-
First UrologyJeffersonvilleIndiana47130-
Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of MarylandBaltimoreMaryland21201-
Maryland Oncology HematologySilver SpringMaryland20904-
KarmanosDetroitMichigan48201-
Minnesota Oncology HematologyMinneapolisMinnesota55404-
Memorial Sloane Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
MidLantic UrologyBala-CynwydPennsylvania19004-
Keystone Urology SpecialistsLancasterPennsylvania17601-
Amarillo Urology ResearchAmarilloTexas74035-
Urology Clinics of North TexasDallasTexas75231-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112-
Virginia Oncology AssociatesFairfaxVirginia22031-
Virginia Cancer SpecialistsNorfolkVirginia23502-
University of Washington, Fred Hutchinson Cancer CenterSeattleWashington98109-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Colorado Springs, CO

By research site
Rocky Mountain Cancer Center· Colorado Springs, COSouth Florida Oncology and Hematology· Plantation, FLIllinois Cancer Specialists· Arlington Heights, ILComprehensive Urologic Care· Lake Barrington, ILFirst Urology· Jeffersonville, INMarlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland· Baltimore, MD

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