Dear Taiwan Urological Association,
On behalf of ORIC Pharmaceuticals, Inc., ICON Clinical Research is pleased to share information on an upcoming Phase III study of ORIC-944 in combination with darolutamide in patients with metastatic castration resistant prostate cancer (mCRPC) who have previously been treated with abiraterone acetate.
About the Study
The Polycomb Repressive Complex 2 (PRC2) has emerged as a key regulator of lineage plasticity and therapeutic resistance in advanced prostate cancer. Activation of alternative lineage pathways that bypass Androgen Receptor signaling leads to an androgen-independent state and loss of Androgen Receptor Pathway Inhibitor (ARPI) efficacy. Inhibition of PRC2 may suppress plasticity, restore luminal identity, and enhance ARPI efficacy. Preclinical and early clinical studies support the combination of PRC2 inhibition with ARPIs to counteract resistance and improve outcomes.
ORIC-944 is a potent, highly selective, orally bioavailable, potential best-in-class inhibitor of PRC2. ORIC-944 inhibits PRC2 activation and blocks the maintenance of repressive chromatin states associated with tumor progression and ARPI resistance. Early clinical data from the Phase 1b study have demonstrated a favorable safety profile, an extended half-life supporting once-daily dosing, and encouraging efficacy when combined with darolutamide, in mCRPC patients previously treated only with abiraterone.
We would greatly value your support in:
- Circulating information about this study to your members
- Identifying investigators who may have a strong interest in advanced prostate cancer research, and
- Sharing recommendations for potential clinical sites
Study detail summary
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Investigational Treatment: |
ORIC-944 (QD) in combination with darolutamide (BID) |
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Patient Profile: |
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Study Timelines |
Expected First Patient Screened: Q2 2026 Enrollment period: 15 months |
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Target Number of Patients |
600 |
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Comparator Arm: |
Enzalutamide or Docetaxel (physician’s choice) |
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Site Requirements: |
Access to CT or MRI scan TC-99m MDP (Technetium Tc99 Methylene Diphosphonate) Bone Scan Capability Local lab (Hematology/Chemistry) PK capabilities (Blood draw and plasma preparation) Proficient in RECIST 1.1 and PCWG3 |
Confidentiality agreement
To share the full protocol synopsis and additional study details, we would need a Confidential Disclosure Agreement (CDA) in place. We assume institutional CDAs are preferred; however, please let us know your network’s preference so that we may provide the appropriate agreement.
We sincerely appreciate your consideration and support in helping to connect this important study with the prostate cancer research community. We would be happy to provide additional information or arrange a call at your convenience.
Yours sincerely,
Hsin-Ying
Hsin-Ying Huang黃心穎, PhD
Clinical Trial Liaison
Site Engagement – Asia-Pacific
Site & Patient Solutions
Tel: +886 2 7706 6288
Mobile: +886 928 804 627
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