OncoMatch/Clinical Trials/NCT07723248
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Is NCT07723248 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including Rinzimetostat and Darolutamide for metastatic castration resistant prostate cancer.
Treatment: Rinzimetostat · Darolutamide · Enzalutamide · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Endocrine / hormonal
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Demographics
Prior therapy
Must have received: abiraterone acetate (abiraterone acetate) — mCSPC or first line mCRPC
evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required
Cannot have received: cytotoxic chemotherapy
Exception: 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
Prior treatment for prostate cancer at any stage with cytotoxic chemotherapy...with the following exceptions: 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
Cannot have received: radioligand therapy (177Lu-PSMA-617, radium-223)
Prior treatment for prostate cancer at any stage with radioligand therapy (ie, 177Lu -PSMA-617, radium-223)
Cannot have received: androgen receptor pathway inhibitor (apalutamide, darolutamide, enzalutamide)
Exception: Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication
Prior treatment for prostate cancer at any stage with ARPIs including apalutamide, darolutamide, and enzalutamide, 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
Cannot have received: PARP inhibitor
Prior treatment for prostate cancer at any stage with PARP monotherapy
Cannot have received: systemic anticancer treatment
Exception: approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene or cell therapy, angiogenesis inhibitors, CDK4/6 inhibitors, PRC2 inhibitors
Prior treatment for prostate cancer at any stage with 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)
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Urology Specialists of the Carolinas - University Place · Charlotte, North Carolina
- Summit Urology · Murray, Utah
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07723248 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytotoxic chemotherapy, radioligand therapy, androgen receptor pathway inhibitor disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages