Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Himalayas-1 is a global phase 3 trial comparing the rinzimetostat and darolutamide combo against physician's choice of control therapy, which may include an ARPI (darolutamide or enzalutamide) or docetaxel. The trial is randomized and open-label, enrolling adults with metastatic prostate cancer that progressed on abiraterone. Participants have favorable performance status and adequate organ function, and have documented metastatic disease. The primary endpoint is radiographic progression-free survival, with secondary considerations around safety and other clinical outcomes. Lead sponsor is ORIC Pharmaceuticals with Bayer as a collaborator, enrolling at multiple U.S. sites.

Why it matters

Who can join: the full rules

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

Where it's running

• Oncura Health
  Glendale, California, United States Recruiting
• SSAK Partners, LLC
  Coral Springs, Florida, United States Recruiting
• First Urology PSC
  Jeffersonville, Indiana, United States Recruiting
• Cancer And Hematology Centers Of Western Michigan
  Holland, Michigan, United States Recruiting
• Urology Specialists of the Carolinas - University Place
  Charlotte, North Carolina, United States Recruiting
• Gabrail Cancer Center Research
  Canton, Ohio, United States Recruiting

Study contacts

• Study coordinator: ORIC Clinical Call Center
• Email: clinical@oricpharma.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AZD2265 plus standard care vs standard care in PSMA-positive metastatic castration-resistant prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.