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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07723248

Public ClinicalTrials.gov record NCT07723248. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 4:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07723248
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
ORIC Pharmaceuticals
Industry
Enrollment
600 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2, 2026
Primary completion
Feb 29, 2028
Completion
Aug 31, 2030
Last update posted
Sep 2, 2026

2026 – 2030

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
7
Facility City State ZIP Site status
First Urology PSC Jeffersonville Indiana 40207 Recruiting
Urology Specialists of the Carolinas - University Place Charlotte North Carolina 29464 Recruiting
Gabrail Cancer Center Research Canton Ohio 44718 Recruiting
Urology Clinics Of North Texas Dallas Texas 75231 Recruiting
Urology Partners of North Texas (UPNT) Fort Worth Texas 76132 Recruiting
Houston Metro Urology (HMU) Houston Texas 77027 Recruiting
Summit Urology Murray Utah 84107 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07723248, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 2, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07723248 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →