Rinzimetostat + Darolutamide for Prostate Cancer
(Himalayas-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for men with metastatic prostate cancer that has stopped responding to hormone therapy and abiraterone. Participants must be in good physical condition, have confirmed prostate adenocarcinoma (not small cell), show disease progression, and have healthy organs. People with brain metastases, serious heart issues, or recent other cancer treatments can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the investigational combination of rinzimetostat with darolutamide or the physician's choice of control (ARPI or docetaxel)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Darolutamide
- Docetaxel
- Enzalutamide
- Rinzimetostat
Trial Overview
The study compares a new drug combo—rinzimetostat plus darolutamide—to standard treatments chosen by doctors: either another hormone therapy (darolutamide or enzalutamide) or chemotherapy (docetaxel). Patients are randomly assigned to one of these groups.
How Is the Trial Designed?
2
Treatment groups
Active Control
Rinzimetostat + darolutamide
Control Arm
Find a Clinic Near You
Who Is Running the Clinical Trial?
ORIC Pharmaceuticals
Lead Sponsor
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
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