Recruiting
Phase 3

Rinzimetostat & Darolutamide

Sponsor:

ORIC Pharmaceuticals

Code:

NCT07723248

Conditions

Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rinzimetostat

Darolutamide

Enzalutamide

Docetaxel

Study Details

Brief summary:

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.

Conditions

Metastatic Castration Resistant Prostate Cancer

Study ID

NCT07723248

Start date

Aug 3, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
  • Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function

Exclusion Criteria:

  • Prior treatment for prostate cancer at any stage with cytotoxic chemotherapy, radioligand therapy (ie, 177Lu -PSMA-617, radium-223), ARPIs including apalutamide, darolutamide, and enzalutamide, PARP monotherapy or other systemic anticancer treatment (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene or cell therapy, angiogenesis inhibitors, CDK4/6 inhibitors, PRC2 inhibitors) with the following exceptions:

1. Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure or disease progression occurred during treatment or within 3 months of treatment completion
  • Any other anticancer therapy (drug or vaccine which does not meet exclusion criterion 1 above) within 28 days or 5 half-lives (whichever is longer) prior to randomization
  • Known or suspected brain metastasis or active leptomeningeal disease
  • Clinically significant cardiovascular disease defined as:
  • Any medical (including active or clinically significant bacterial, fungal, or viral infection) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study
  • Active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery are excluded

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Investigational Arm

Rinzimetostat + darolutamide

active comparator: Physician's Choice

Control Arm

Interventions

Rinzimetostat

400 mg once daily (QD)

Darolutamide

600 mg twice daily (BID)

Enzalutamide

160 mg once daily (QD)

Docetaxel

75 mg/m2 intravenously (IV) every 21 days for up to 10 cycles

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 and Locations

Central contacts

ORIC Clinical Call Center

clinical@oricpharma.com

Locations

SSAK Partners, LLC

Recruiting

Coral Springs, Florida, United States, 33065

First Urology PSC

Recruiting

Jeffersonville, Indiana, United States, 40207

Cancer And Hematology Centers Of Western Michigan

Recruiting

Holland, Michigan, United States, 49424

Urology Specialists of the Carolinas - University Place

Recruiting

Charlotte, North Carolina, United States, 29464

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Urology Associates

Recruiting

Nashville, Tennessee, United States, 37209

Urology Clinics Of North Texas

Recruiting

Dallas, Texas, United States, 75231

Urology Partners of North Texas (UPNT)

Recruiting

Fort Worth, Texas, United States, 76132

Houston Metro Urology (HMU)

Recruiting

Houston, Texas, United States, 77027

Summit Urology

Recruiting

Murray, Utah, United States, 84107

More Information

Sponsor

ORIC Pharmaceuticals

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

  • prostate cancer
  • advanced prostate cancer
  • hormone dependent malignancy
  • hormone resistant
  • relapsed
  • refractory
  • androgen receptor (AR) signaling
  • metastatic castration resistant prostate cancer (mCRPC)
  • androgen pathway modulator-resistant (APMR)
  • metastatic castration sensitive prostate cancer (mCSPC)
  • androgen pathway modulator-naïve/sensitive (APMN/S)
  • polycomb repressive complex 2 (PRC2)-controlled dysregulation
  • embryonic ectoderm development (EED)
  • enhancer of zeste homolog 2 (EZH2)
  • ORIC-944
  • rinzimetostat
  • mevrometostat
  • darolutamide
  • enzalutamide
  • docetaxel
  • abiraterone
  • abiraterone acetate
  • efficacy
  • safety
  • open-label

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by ORIC Pharmaceuticals on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.