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Taking people in Puerto RicoPhase 3

Tests rinzimetostat with darolutamide in advanced prostate cancer after abiraterone

Tests rinzimetostat plus darolutamide in men with advanced prostate cancer previously treated with abiraterone.

Key facts

Who runs it
ORIC Pharmaceuticals
Where
San Juan, Puerto RicoSee the siteAlso in 1 other country, 14 sites
Registry title
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Status
Recruiting
Phase
Phase 3
People taking part
600 people, planned
Started
3 Aug 2026
Expected to end
Sept 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Rinzimetostat
  • Darolutamide
  • Enzalutamide
  • Docetaxel
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer that has spread and no longer responds to hormone-lowering treatment, and that grew during abiraterone acetate treatment.

Age
18 years or older
Sex
Men only
Disease stage
Prostate adenocarcinoma without small cell features, spread to bone or soft tissue, castration-resistant, with disease progression on abiraterone acetate. ECOG performance status 0 or 1.
Earlier treatment
Must have had abiraterone acetate, with progression on it. Cannot have had earlier chemotherapy, radioligand therapy, or other hormone-blocking drugs such as apalutamide, darolutamide or enzalutamide. First-generation antiandrogens like bicalutamide are allowed if stopped before the first dose. Docetaxel is allowed only for hormone-sensitive disease, with no progression during or within 3 months after it.

Main reasons for not taking part

  • Known or suspected brain metastasis or active leptomeningeal disease
  • Clinically significant cardiovascular disease
  • Other anticancer therapy within 28 days or 5 half-lives before randomization
  • Active inflammatory bowel disease, chronic diarrhea, or previous gastric resection or lap-band surgery
  • Medical or psychiatric condition that raises the risk of taking part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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:; Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication; 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
  • Active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery are excluded
  • 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

Where in Puerto Rico

Also in 1 other country, 14 sites

  • BRCR Global (Network)San Juan, Puerto RicoTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Investigational ArmExisting treatment, for comparison

    Rinzimetostat + darolutamide

    Treatment: Rinzimetostat and Darolutamide

  • Physician's ChoiceExisting treatment, for comparison

    Control Arm

    Treatment: Darolutamide, Enzalutamide, and Docetaxel

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Plain-language title
Tests rinzimetostat with darolutamide in advanced prostate cancer after abirateroneGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026