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RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests rinzimetostat (ORIC-944) plus darolutamide against a doctor's choice of darolutamide, enzalutamide, or docetaxel. It is for people whose prostate cancer has spread and keeps growing despite treatment to lower testosterone, and who previously took abiraterone acetate. The study checks whether the drug pair delays cancer growth seen on scans.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue or cell test confirms prostate adenocarcinoma, a type of prostate cancer, with no small cell features.
  • Cancer has worsened despite surgery or medicine to lower testosterone. It must have worsened while taking abiraterone for cancer that had spread, either while still responding to hormone treatment or as the first treatment after it stopped responding.
  • A bone scan, CT scan, or MRI shows cancer has spread to bones or soft tissues.
  • You can do all usual activities, or only have trouble with hard physical activity.
  • Your organs work well enough for the study.

Who can't join

  • Past prostate cancer treatment with chemotherapy, targeted radiation drugs, apalutamide, darolutamide, enzalutamide, a PARP drug used alone, or other cancer drugs that work throughout the body. Exceptions are listed below.
  • Older hormone-blocking drugs, such as bicalutamide, are allowed but must stop before the first study dose. Past docetaxel is allowed for cancer that had spread but still responded to hormone treatment, if treatment did not fail and cancer did not worsen during treatment or within 3 months afterward.
  • Other cancer drugs or vaccines taken too recently before assignment to a study group: within 28 days or the time needed for the drug's amount in the body to halve 5 times, whichever is longer.
  • Known or suspected cancer spread to the brain, or active cancer in the lining around the brain and spinal cord.
  • Significant heart or blood vessel disease.
  • A health condition, mental health condition, infection, or abnormal lab result that could make the study unsafe or unsuitable. This includes current suicidal thoughts or behavior, or these within the past year.
  • Active inflammation in the stomach or intestines, long-term diarrhea, past surgery to remove part or all of the stomach, or past lap-band surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (11)

FL

IN

MI

NC

OH

SC

TN

TX

UT