A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
ORIC Pharmaceuticals
Study ID
NCT07723248
Phase
PHASE3
Status
Recruiting
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Conditions

  • Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

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

Interventions

  • Rinzimetostat — DRUG
    400 mg once daily (QD)
  • Darolutamide — DRUG
    600 mg twice daily (BID)
  • Enzalutamide — DRUG
    160 mg once daily (QD)
  • Docetaxel — DRUG
    75 mg/m2 intravenously (IV) every 21 days for up to 10 cycles

Study Details

Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or enzalutamide) or docetaxel for treating patients with metastatic castration resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate. The primary objective of this study is to demonstrate superiority in radiographic progression free survival (rPFS) of the investigational arm of rinzimetostat + darolutamide combination versus physician's choice of control: ARPI (darolutamide or enzalutamide) or docetaxel.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Sep 30, 2030

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Investigational Arm
    Rinzimetostat + darolutamide
  • Active Comparator: Physician's Choice
    Control Arm

Primary Outcome Measure

Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) [ Time Frame: Randomization up to ~2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Urology Specialists of the Carolinas - University PlaceCharlotteNorth Carolina29464
Jeremy Hubbard, MD (PRINCIPAL_INVESTIGATOR)
Summit UrologyMurrayUtah84107
Stewart Landau, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlotte, NC

By research site
Urology Specialists of the Carolinas - University Place· Charlotte, NCSummit Urology· Murray, UT

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